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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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To evaluate the safety and effectiveness of the Model 400 aortic valve bioprosthesis.
This is a prospective, interventional, non-randomized, worldwide, multi-center trial. A maximum of 1300 subjects were to be implanted at a maximum of 40 sites in the US, Europe and Canada. The trial includes male and female patients of legal age to provide informed consent in the country where they enrolled in the trial, requiring replacement for a diseased, damaged, or malfunctioning native or prosthetic aortic valve. Subjects are followed out to 5 years, and select sites follow subjects out to 12 years. Enrollment closed on 14Jul2017 for all valve sizes. Enrollment was reopened in Apr2019 for the 29mm valve size at a subset of US and Canadian sites to obtain greater patient numbers required by the FDA to support US commercial approval of this valve size. Enrollment for the 29mm valve size closed on 14Feb2023.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Model 400 aortic valve bioprosthesis | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Model 400 aortic valve bioprosthesis | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Safety of the valve is evaluated by the time-related incidence of valve-related adverse events and death. The following valve-related adverse events are evaluated in this study: Thromboembolism, Thrombosis, Hemorrhage, Paravalvular leak (PVL), Endocarditis, Hemolysis, Structural valve deterioration, Non-structural dysfunction, Reintervention, Explant, and Death. A minimum of 15 participants per valve size are evaluated. The incidence rates will be used to summarize valve-related adverse events and death. | 1 year post-implant |
| Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | At each timepoint, a minimum of 15 participants per valve size evaluated for change in New York Heart Association (NYHA) functional classification from baseline to 1 year post-procedure. Measure Description: Cardiac Disease with Functional Classes (lower value is more desirable than higher value) I - No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath. II - Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain. III - Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain. IV - Symptoms of heart failure at rest. Any physical activity causes further discomfort. | Discharge (up to 30 days), 3-6 months, and 1 year post-implant |
| Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Effective Orifice Area Through 1 Year Post-procedure | A minimum of 15 participants per valve size evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory. The effective orifice area (EOA) is measured as the minimal cross-sectional area of the blood flow downstream of the aortic valve. | Discharge (up to 30 days), 3-6 months, 1 year post-implant |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death Annually Through 5 Years Post-implant | Safety of the valve is evaluated by the time-related incidence of valve-related adverse events and death. The following valve-related adverse events are evaluated in this study: Thromboembolism, Thrombosis, Hemorrhage, Paravalvular leak (PVL), Endocarditis, Hemolysis, Structural valve deterioration, Non-structural dysfunction, Reintervention, Explant, and Death. The Kaplan-Meier event rates will be used to summarize valve-related adverse events and death. The Kaplan-Meier rate and the corresponding 95% confidence interval will be presented for each visit interval. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant (Remaining Data From 29mm Valve Participants Not Required for Meeting Primary Outcomes) | Safety of the valve is evaluated by the time-related incidence of valve-related adverse events and death. The following valve-related adverse events are evaluated in this study: Thromboembolism, Thrombosis, Hemorrhage, Paravalvular leak (PVL), Endocarditis, Hemolysis, Structural valve deterioration, Non-structural dysfunction, Reintervention, Explant, and Death. A minimum of 15 participants per valve size are evaluated. The Kaplan-Meier event rates will be used to summarize valve-related adverse events and death. The Kaplan-Meier rate and the corresponding 95% confidence interval will be presented for each visit interval. |
Inclusion Criteria:
Patient has moderate or greater aortic stenosis or regurgitation, and there is clinical indication for replacement of their native or prosthetic aortic valve with a bioprosthesis, with or without concomitant procedures, which are limited to any of the following:
i. Left atrial appendage (LAA) ligation ii. CABG (coronary artery bypass grafting) iii. Patent foramen ovale (PFO) closure iv. Ascending aortic aneurysm or dissection repair not requiring circulatory arrest v. Resection of a sub-aortic membrane not requiring myectomy
Patient is geographically stable and willing to return to the implanting site for all follow-up visits
Patient is of legal age to provide informed consent in the country where they enroll in the trial
Patient has been adequately informed of risks and requirements of the trial and is willing and able to provide informed consent for participation in the clinical trial
Exclusion Criteria:
Patient has a pre-existing prosthetic valve or annuloplasty device in another position or requires replacement or repair of the mitral, pulmonary or tricuspid valve
Patient has had previous implant and then explant of the Model 400 aortic valve bioprosthesis
Patient presents with active endocarditis, active myocarditis or other systemic infection
Patient has an anatomical abnormality which would increase surgical risk of morbidity or mortality, including:
Patient has a non-cardiac major or progressive disease, with a life expectancy of less than 2 years. These conditions include, but are not limited to:
Patient has renal failure, defined as dialysis therapy or glomerular filtration rate(GFR)<30 mL/min/1.73 m2
Patient has hyperparathyroidism
Patient is participating in another investigational device or drug trial or observational competitive study
Patient is pregnant, lactating or planning to become pregnant during the trial period
Patient has a documented history of substance (drug or alcohol) abuse
Patient has greater than mild mitral valve regurgitation or greater than mild tricuspid valve regurgitation as assessed by echocardiography
Patient has systolic ejection fraction (EF)<20% as assessed by echocardiography
Patient has Grade IV Diastolic Dysfunction
Patient has documented bleeding diatheses
Patient has had an acute preoperative neurological deficit or myocardial infarction and has not returned to baseline or stabilized ≥30 days prior to enrollment
Patient requires emergency surgery
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Sabik, MD | University Hospital Cleveland Medical Center (Not a recruiting site) | Principal Investigator |
| Prof. Dr. Robert Johannes Menno Klautz, MD | Leiden University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California (USC) University Hospital | Los Angeles | California | 90033-5313 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39624936 | Derived | Velders BJJ, Vriesendorp MD, Weissman NJ, Sabik JF 3rd, Reardon MJ, Dagenais F, Moront MG, Rao V, Fukuhara S, Gunzinger R, van Leeuwen WJ, Brown WM, Groenwold RHH, Klautz RJM, Asch FM. Core Laboratory Versus Center-Reported Echocardiographic Assessment of the Native and Bioprosthetic Aortic Valve. Echocardiography. 2024 Dec;41(12):e70047. doi: 10.1111/echo.70047. | |
| 38710669 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Medtronic Model 400 Avalus Bioprosthetic Aortic Valve | The Medtronic Model 400 Avalus Bioprosthetic Aortic Valve is indicated for patients who require replacement of their native aortic valve. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 13, 2019 | Aug 27, 2019 |
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| Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Effective Orifice Area Index (EOAI) Through 1 Year Post-implant | A minimum of 15 participants per valve size evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory for effective orifice area index (EOAI = EOA/BSA) Effective orifice area index is equal to the effective orifice area (EOA) in cm^2 divided by body surface area (BSA) in m^2. The achievement criterion for the effective orifice area index (EOAI) is defined to be ≥0.6 cm^2/m^2 12 months after the procedure. This criterion is in accordance with the definition of severe aortic stenosis in the American College of Cardiology (ACC) / American Heart Association (AHA) guidelines for the management of valvular heart disease. | Discharge (up to 30 days), 3-6 months, and 1 year post-implant |
| Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Peak Pressure Gradient (mmHg) From Discharge up to 1 Year | A minimum of 15 participants per valve size evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory. The peak pressure gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. | Measured at discharge (up to 30 days), 3-6 months, and 1 year post-implant |
| Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Mean Pressure Gradient (mmHg) Through 1 Year Post-implant | A minimum of 15 participants per valve size evaluated by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The mean pressure gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. | Discharge (up to 30 days), 3-6 months, and 1 year post-implant |
| Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Performance Index (L/Min) Through 1 Year Post-implant | A minimum of 15 participants per valve size will have performance index (L/Min) measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The performance index is the measurement of the effective orifice area divided by the native orifice area. | Discharge (up to 30 days), 3-6 months, and 1 year post-implant |
| Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Output (L/Min) Through 1 Year Post-implant | Cardiac output is the amount of blood pumped by the heart per minute. A minimum of 15 participants per valve size were evaluated for this outcome measure by transthoracic echocardiography technique and assessed by an independent core laboratory. | Discharge (up to 30 days), 3-6 months, and 1 year post-implant |
| Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Index (L/Min/m^2) Through 1 Year Post-implant | A minimum of 15 participants per valve size evaluated by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The cardiac index is an assessment of the cardiac output based on a patient's size measured by dividing the cardiac output by the patient's body's surface area. | Discharge (up to 30 days), 3-6 months, and 1 year post-implant |
| Annually, at years 2, 3, 4, and 5 post-implant |
| Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 5 Years Post-implant | At each timepoint, participants were evaluated for change in New York Heart Association (NYHA) functional classification from baseline through 5 years post-procedure. Measure Description: Cardiac Disease with Functional Classes (lower value is more desirable than higher value) I - No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath. II - Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain. III - Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain. IV - Symptoms of heart failure at rest. Any physical activity causes further discomfort. | Annually, at years 2, 3, 4, and 5 post-implant |
| Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Effective Orifice Area Through 5 Years Post-procedure | Evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory. The effective orifice area (EOA) is measured as the minimal cross-sectional area of the blood flow downstream of the aortic valve. | Annually, at years 2, 3, 4, and 5 post-implant |
| Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Effective Orifice Area Index (EOAI) Through 5 Years Post-implant | Evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory for effective orifice area index (EOAI = EOA/BSA) Effective orifice area index is equal to the effective orifice area (EOA) in cm^2 divided by body surface area (BSA) in m^2. The achievement criterion for the effective orifice area index (EOAI) is defined to be ≥0.6 cm^2/m^2 12 months after the procedure. This criterion is in accordance with the definition of severe aortic stenosis in the American College of Cardiology (ACC) / American Heart Association (AHA) guidelines for the management of valvular heart disease. | Annually, at years 2, 3, 4, and 5 post-implant |
| Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Peak Pressure Gradient (mmHg) From Discharge up to 5 Years Post-implant | Evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory. The peak pressure gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. | Annually, at years 2, 3, 4, and 5 post-implant |
| Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Mean Pressure Gradient (mmHg) Through 5 Years Post-implant | Evaluated by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The mean pressure gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. | Annually, at years 2, 3, 4, and 5 post-implant |
| Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Performance Index (L/Min) Through 5 Years Post-implant | Performance index (L/Min) measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The performance index is the measurement of the effective orifice area divided by the native orifice area. | Annually, at years 2, 3, 4, and 5 post-implant |
| Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Output (L/Min) Through 5 Years Post-implant | Cardiac output is the amount of blood pumped by the heart per minute, evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory. | Annually, at years 2, 3, 4, and 5 post-implant |
| Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Index (L/Min/m^2) Through 5 Years Post-implant | Evaluated by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The cardiac index is an assessment of the cardiac output based on a patient's size measured by dividing the cardiac output by the patient's body's surface area. | Annually, at years 2, 3, 4, and 5 post-implant |
| 1 year post-implant |
| Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year (Remaining Data From 29mm Valve Participants Not Required for Meeting Primary Outcomes) | Participants evaluated for change in New York Heart Association (NYHA) functional classification from baseline to 1 year post-procedure. Measure Description: Cardiac Disease with Functional Classes (lower value is more desirable than higher value) I - No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath. II - Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain. III - Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain. IV - Symptoms of heart failure at rest. Any physical activity causes further discomfort. | 3-6 months and 1 year post-implant |
| Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Effective Orifice Area Through 1 Year Post-procedure (Remaining Data From 29mm Valve Participants Not Required for Meeting Primary Outcomes) | Evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory. The effective orifice area (EOA) is measured as the minimal cross-sectional area of the blood flow downstream of the aortic valve. | 3-6 months, 1 year post-implant |
| Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Effective Orifice Area Index (EOAI) Through 1 Year Post-implant (Remaining Data From 29mm Valve Participants Not Required for Meeting Primary Outcomes) | Evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory for effective orifice area index (EOAI = EOA/BSA) Effective orifice area index is equal to the effective orifice area (EOA) in cm^2 divided by body surface area (BSA) in m^2. The achievement criterion for the effective orifice area index (EOAI) is defined to be ≥0.6 cm^2/m^2 12 months after the procedure. This criterion is in accordance with the definition of severe aortic stenosis in the American College of Cardiology (ACC) / American Heart Association (AHA) guidelines for the management of valvular heart disease. | 3-6 months, and 1 year post-implant |
| Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Peak Pressure Gradient (mmHg) From Discharge up to 1 Year (Remaining Data From 29mm Valve Participants Not Required for Meeting Primary Outcomes) | Evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory. The peak pressure gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. | 3-6 months, and 1 year post-implant |
| Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Mean Pressure Gradient (mmHg) Through 1 Year Post-implant (Remaining Data From 29mm Valve Participants Not Required for Meeting Primary Outcomes) | Evaluated by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The mean pressure gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. | 3-6 months, and 1 year post-implant |
| Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Performance Index (L/Min) Through 1 Year Post-implant (Remaining Data From 29mm Valve Participants Not Required for Meeting Primary Outcomes) | Performance index (L/Min) measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The performance index is the measurement of the effective orifice area divided by the native orifice area. | 3-6 months, and 1 year post-implant |
| Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Output (L/Min) Through 1 Year Post-implant (Remaining Data From 29mm Valve Participants Not Required for Meeting Primary Outcomes) | Cardiac output is the amount of blood pumped by the heart per minute. Evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory. | 3-6 months, and 1 year post-implant |
| Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Index (L/Min/m^2) Through 1 Year Post-implant (Remaining Data From 29mm Valve Participants Not Required for Meeting Primary Outcomes) | Evaluated by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The cardiac index is an assessment of the cardiac output based on a patient's size measured by dividing the cardiac output by the patient's body's surface area. | 3-6 months, and 1 year post-implant |
| Confirm the Effectiveness of the Model 400 Avalus Valve by Clinically Acceptable Hemodynamic Performance From Years 6 Through 12 Post-implant. | Long-term follow-up clinically acceptable hemodynamic performance defined as freedom from surgical explant and/or percutaneous valve-in-valve reintervention due to structural valve deterioration | Annually, years 6-12 post-implant |
| Confirm the Effectiveness of the Model 400 Avalus Valve From Years 6 - 12 Post-implant by Freedom From Valve-related Death | Annually, years 6 though 12 post-implant |
| Confirm the Effectiveness of the Model 400 Avalus Valve From Years 6 - 12 Post-implant by Freedom From All-cause Mortality | For time-to-event outcomes, Kaplan-Meier (actuarial) analysis of the event-free rate performed annually through twelve years. | Annually, years 6 though 12 post-implant |
| Confirm the Effectiveness of the Model 400 Avalus Valve From Years 6 - 12 Post-implant by Change in NYHA Functional Classification Status From Baseline | Annually, years 6 though 12 post-implant |
| Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Effective Orifice Area Through 12 Years Post-procedure | Evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory. The effective orifice area (EOA) is measured as the minimal cross-sectional area of the blood flow downstream of the aortic valve. | Annually, years 6 though 12 post-implant |
| Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Effective Orifice Area Index (EOAI) Through 12 Years Post-implant | Evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory for effective orifice area index (EOAI = EOA/BSA) Effective orifice area index is equal to the effective orifice area (EOA) in cm^2 divided by body surface area (BSA) in m^2. The achievement criterion for the effective orifice area index (EOAI) is defined to be ≥0.6 cm^2/m^2 12 months after the procedure. This criterion is in accordance with the definition of severe aortic stenosis in the American College of Cardiology (ACC) / American Heart Association (AHA) guidelines for the management of valvular heart disease. | Annually, years 6 though 12 post-implant |
| Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Peak Pressure Gradient (mmHg) up to 12 Years Post-implant | Evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory. The peak pressure gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. | Annually, years 6 though 12 post-implant |
| Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Mean Pressure Gradient (mmHg) Through 12 Years Post-implant | Evaluated by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The mean pressure gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. | Annually, years 6 though 12 post-implant |
| Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Performance Index (L/Min) Through 12 Years Post-implant | Performance index (L/Min) measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The performance index is the measurement of the effective orifice area divided by the native orifice area. | Annually, years 6 though 12 post-implant |
| Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Output (L/Min) Through 12 Years Post-implant | Cardiac output is the amount of blood pumped by the heart per minute. Evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory. | Annually, years 6 though 12 post-implant |
| Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Index (L/Min/m^2) Through 12 Years Post-implant | Evaluated by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The cardiac index is an assessment of the cardiac output based on a patient's size measured by dividing the cardiac output by the patient's body's surface area. | Annually, years 6 though 12 post-implant |
| University of Colorado Hospital |
| Aurora |
| Colorado |
| 80045-2545 |
| United States |
| Hartford Hospital | Hartford | Connecticut | 06102 | United States |
| University of Florida Shands | Gainesville | Florida | 32610 | United States |
| Piedmont Hospital | Atlanta | Georgia | 30309 | United States |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| University of Michigan Cardiovascular Center | Ann Arbor | Michigan | 48109-5853 | United States |
| Minneapolis Heart Institute Foundation | Minneapolis | Minnesota | 55407-1139 | United States |
| Maimonides Medical Center | Brooklyn | New York | 11219 | United States |
| The Mount Sinai Medical Center | New York | New York | 10029 | United States |
| New York-Presbyterian Hospital/Columbia University Medical Center | New York | New York | 10032 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195-0001 | United States |
| Riverside Methodist Hospital (OhioHealth) | Columbus | Ohio | 43214 | United States |
| ProMedica Toledo Hospital | Toledo | Ohio | 43606 | United States |
| Oklahoma Heart Hospital | Oklahoma City | Oklahoma | 73135 | United States |
| Cardiothoracic and Vascular Surgeons (CTVS) | Austin | Texas | 78756-4080 | United States |
| Houston Methodist Hospital | Houston | Texas | 77030 | United States |
| University of Washington Medical Center | Seattle | Washington | 98195-0001 | United States |
| Aurora Saint Luke's Medical Center | Milwaukee | Wisconsin | 53215-4330 | United States |
| London Health Sciences Centre - University Campus | London | Ontario | N6A 5A5 | Canada |
| University of Ottawa Heart Institute | Ottawa | Ontario | K1Y 4W7 | Canada |
| Montreal Heart Institute | Montreal | Quebec | H1T 1C8 | Canada |
| Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ) | Québec | G1V 4G5 | Canada |
| Toronto General Hospital | Toronto | M5G 2C4 | Canada |
| Hôpital Cardiologique du Haut-Lévêque | Bordeaux | 33604 | France |
| Hôpital Bichat - Claude Bernard | Paris | 75018 | France |
| Uniklinik Köln | Cologne | Köln | 50924 | Germany |
| Deutsches Herzzentrum München | Munich | München | DE 80636 | Germany |
| Universitäts Klinikum Frankfurt - Goethe-Universität | Frankfurt | 60590 | Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| Herzzentrum Leipzig GmbH | Leipzig | 04289 | Germany |
| Ospedale San Raffaele - Milano | Milan | 20132 | Italy |
| Leids Universitair Medisch Centrum (LUMC) | Leiden | 2333 ZA | Netherlands |
| Erasmus MC | Rotterdam | 3015 CE | Netherlands |
| Inselspital - Universitätsspital Bern | Bern | 3010 | Switzerland |
| UniversitätsSpital Zürich | Zurich | 8091 | Switzerland |
| Guy's & St Thomas' NHS Foundation Trust - St Thomas' Hospital | London | SE1 7EH | United Kingdom |
| Klautz RJM, Rao V, Reardon MJ, Deeb GM, Dagenais F, Moront MG, Little SH, Labrousse L, Patel HJ, Ito S, Li S, Sabik JF 3rd, Oh JK. Examining the typical hemodynamic performance of nearly 3000 modern surgical aortic bioprostheses. Eur J Cardiothorac Surg. 2024 May 3;65(5):ezae122. doi: 10.1093/ejcts/ezae122. |
| 36963820 | Derived | Velders BJJ, Vriesendorp MD, De Lind Van Wijngaarden RAF, Rao V, Reardon MJ, Shrestha M, Chu MWA, Sabik JF 3rd, Liu F, Klautz RJM. Perioperative care differences of surgical aortic valve replacement between North America and Europe. Heart. 2023 Jun 26;109(14):1106-1112. doi: 10.1136/heartjnl-2023-322350. |
| 28475690 | Derived | Klautz RJM, Kappetein AP, Lange R, Dagenais F, Labrousse L, Bapat V, Moront M, Misfeld M, Zeng C, Sabik Iii JF; PERIGON Investigators. Safety, effectiveness and haemodynamic performance of a new stented aortic valve bioprosthesis. Eur J Cardiothorac Surg. 2017 Sep 1;52(3):425-431. doi: 10.1093/ejcts/ezx066. |
| Implanted |
|
| 1 Year Completion | Primary outcome milestone (a minimum of 15 participants per valve size completes 1 year follow-up) |
|
| COMPLETED | Participants who have completed 5 year follow-up |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Medtronic Model 400 Avalus Bioprosthetic Aortic Valve | Participants implanted with the Medtronic Model 400 Avalus Bioprosthetic Aortic Valve, as indicated for patients who require replacement of their native aortic valve. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| New York Heart Association (NYHA) Classification | Measure of heart failure severity (lower class desirable) I - No limitation of physical activity. Ordinary physical activity does not cause fatigue, palpitation or shortness of breath. II - Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain. III - Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain. IV - Symptoms of heart failure at rest. Any physical activity causes further discomfort. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||
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| Primary | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant | Safety of the valve is evaluated by the time-related incidence of valve-related adverse events and death. The following valve-related adverse events are evaluated in this study: Thromboembolism, Thrombosis, Hemorrhage, Paravalvular leak (PVL), Endocarditis, Hemolysis, Structural valve deterioration, Non-structural dysfunction, Reintervention, Explant, and Death. A minimum of 15 participants per valve size are evaluated. The incidence rates will be used to summarize valve-related adverse events and death. | Posted | Number | percentage of participants with event | 1 year post-implant |
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| Primary | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year | At each timepoint, a minimum of 15 participants per valve size evaluated for change in New York Heart Association (NYHA) functional classification from baseline to 1 year post-procedure. Measure Description: Cardiac Disease with Functional Classes (lower value is more desirable than higher value) I - No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath. II - Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain. III - Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain. IV - Symptoms of heart failure at rest. Any physical activity causes further discomfort. | Difference in the overall number of participants analyzed and of those analyzed at each timepoint is due to classification not assessed, classification was unable to be assessed, or the participant exited the trial before that timepoint. For 29mm participants, difference in total number of participants analyzed was also due to participants who have not yet reached specified timepoint. | Posted | Count of Participants | Participants | Discharge (up to 30 days), 3-6 months, and 1 year post-implant |
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| Primary | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Effective Orifice Area Through 1 Year Post-procedure | A minimum of 15 participants per valve size evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory. The effective orifice area (EOA) is measured as the minimal cross-sectional area of the blood flow downstream of the aortic valve. | At each timepoint, only subjects with echocardiography core lab data are included in the rows below. | Posted | Mean | Standard Deviation | cm^2 | Discharge (up to 30 days), 3-6 months, 1 year post-implant |
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| Primary | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Effective Orifice Area Index (EOAI) Through 1 Year Post-implant | A minimum of 15 participants per valve size evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory for effective orifice area index (EOAI = EOA/BSA) Effective orifice area index is equal to the effective orifice area (EOA) in cm^2 divided by body surface area (BSA) in m^2. The achievement criterion for the effective orifice area index (EOAI) is defined to be ≥0.6 cm^2/m^2 12 months after the procedure. This criterion is in accordance with the definition of severe aortic stenosis in the American College of Cardiology (ACC) / American Heart Association (AHA) guidelines for the management of valvular heart disease. | At each timepoint, only subjects with echocardiography core lab data are included in the rows below. | Posted | Mean | Standard Deviation | cm^2/m^2 | Discharge (up to 30 days), 3-6 months, and 1 year post-implant |
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| Primary | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Peak Pressure Gradient (mmHg) From Discharge up to 1 Year | A minimum of 15 participants per valve size evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory. The peak pressure gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. | At each timepoint, only subjects with echocardiography core lab data are included in the rows below. | Posted | Mean | Standard Deviation | mmHg | Measured at discharge (up to 30 days), 3-6 months, and 1 year post-implant |
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| Primary | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Mean Pressure Gradient (mmHg) Through 1 Year Post-implant | A minimum of 15 participants per valve size evaluated by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The mean pressure gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. | At each timepoint, only subjects with echocardiography core lab data are included in the rows below. | Posted | Mean | Standard Deviation | mmHg | Discharge (up to 30 days), 3-6 months, and 1 year post-implant |
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| Primary | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Performance Index (L/Min) Through 1 Year Post-implant | A minimum of 15 participants per valve size will have performance index (L/Min) measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The performance index is the measurement of the effective orifice area divided by the native orifice area. | At each timepoint, only subjects with echocardiography core lab data are included in the rows below. | Posted | Mean | Standard Deviation | L/min | Discharge (up to 30 days), 3-6 months, and 1 year post-implant |
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| Primary | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Output (L/Min) Through 1 Year Post-implant | Cardiac output is the amount of blood pumped by the heart per minute. A minimum of 15 participants per valve size were evaluated for this outcome measure by transthoracic echocardiography technique and assessed by an independent core laboratory. | At each timepoint, only subjects with echocardiography core lab data are included in the rows below. | Posted | Mean | Standard Deviation | L/min | Discharge (up to 30 days), 3-6 months, and 1 year post-implant |
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| Primary | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Index (L/Min/m^2) Through 1 Year Post-implant | A minimum of 15 participants per valve size evaluated by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The cardiac index is an assessment of the cardiac output based on a patient's size measured by dividing the cardiac output by the patient's body's surface area. | At each timepoint, only subjects with echocardiography core lab data are included in the rows below. | Posted | Mean | Standard Deviation | L/min/m^2 | Discharge (up to 30 days), 3-6 months, and 1 year post-implant |
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| Secondary | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death Annually Through 5 Years Post-implant | Safety of the valve is evaluated by the time-related incidence of valve-related adverse events and death. The following valve-related adverse events are evaluated in this study: Thromboembolism, Thrombosis, Hemorrhage, Paravalvular leak (PVL), Endocarditis, Hemolysis, Structural valve deterioration, Non-structural dysfunction, Reintervention, Explant, and Death. The Kaplan-Meier event rates will be used to summarize valve-related adverse events and death. The Kaplan-Meier rate and the corresponding 95% confidence interval will be presented for each visit interval. | Not Posted | Annually, at years 2, 3, 4, and 5 post-implant | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 5 Years Post-implant | At each timepoint, participants were evaluated for change in New York Heart Association (NYHA) functional classification from baseline through 5 years post-procedure. Measure Description: Cardiac Disease with Functional Classes (lower value is more desirable than higher value) I - No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath. II - Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain. III - Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain. IV - Symptoms of heart failure at rest. Any physical activity causes further discomfort. | Not Posted | Annually, at years 2, 3, 4, and 5 post-implant | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Effective Orifice Area Through 5 Years Post-procedure | Evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory. The effective orifice area (EOA) is measured as the minimal cross-sectional area of the blood flow downstream of the aortic valve. | Not Posted | Annually, at years 2, 3, 4, and 5 post-implant | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Effective Orifice Area Index (EOAI) Through 5 Years Post-implant | Evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory for effective orifice area index (EOAI = EOA/BSA) Effective orifice area index is equal to the effective orifice area (EOA) in cm^2 divided by body surface area (BSA) in m^2. The achievement criterion for the effective orifice area index (EOAI) is defined to be ≥0.6 cm^2/m^2 12 months after the procedure. This criterion is in accordance with the definition of severe aortic stenosis in the American College of Cardiology (ACC) / American Heart Association (AHA) guidelines for the management of valvular heart disease. | Not Posted | Annually, at years 2, 3, 4, and 5 post-implant | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Peak Pressure Gradient (mmHg) From Discharge up to 5 Years Post-implant | Evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory. The peak pressure gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. | Not Posted | Annually, at years 2, 3, 4, and 5 post-implant | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Mean Pressure Gradient (mmHg) Through 5 Years Post-implant | Evaluated by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The mean pressure gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. | Not Posted | Annually, at years 2, 3, 4, and 5 post-implant | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Performance Index (L/Min) Through 5 Years Post-implant | Performance index (L/Min) measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The performance index is the measurement of the effective orifice area divided by the native orifice area. | Not Posted | Annually, at years 2, 3, 4, and 5 post-implant | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Output (L/Min) Through 5 Years Post-implant | Cardiac output is the amount of blood pumped by the heart per minute, evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory. | Not Posted | Annually, at years 2, 3, 4, and 5 post-implant | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Index (L/Min/m^2) Through 5 Years Post-implant | Evaluated by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The cardiac index is an assessment of the cardiac output based on a patient's size measured by dividing the cardiac output by the patient's body's surface area. | Not Posted | Annually, at years 2, 3, 4, and 5 post-implant | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Evaluate the Safety of the Model 400 Avalus Valve With Regard to Valve-related Adverse Events and Death at 1 Year Post-implant (Remaining Data From 29mm Valve Participants Not Required for Meeting Primary Outcomes) | Safety of the valve is evaluated by the time-related incidence of valve-related adverse events and death. The following valve-related adverse events are evaluated in this study: Thromboembolism, Thrombosis, Hemorrhage, Paravalvular leak (PVL), Endocarditis, Hemolysis, Structural valve deterioration, Non-structural dysfunction, Reintervention, Explant, and Death. A minimum of 15 participants per valve size are evaluated. The Kaplan-Meier event rates will be used to summarize valve-related adverse events and death. The Kaplan-Meier rate and the corresponding 95% confidence interval will be presented for each visit interval. | Not Posted | 1 year post-implant | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Change of New York Heart Association (NYHA) Classification From Baseline Through 1 Year (Remaining Data From 29mm Valve Participants Not Required for Meeting Primary Outcomes) | Participants evaluated for change in New York Heart Association (NYHA) functional classification from baseline to 1 year post-procedure. Measure Description: Cardiac Disease with Functional Classes (lower value is more desirable than higher value) I - No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath. II - Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain. III - Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain. IV - Symptoms of heart failure at rest. Any physical activity causes further discomfort. | Not Posted | 3-6 months and 1 year post-implant | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Effective Orifice Area Through 1 Year Post-procedure (Remaining Data From 29mm Valve Participants Not Required for Meeting Primary Outcomes) | Evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory. The effective orifice area (EOA) is measured as the minimal cross-sectional area of the blood flow downstream of the aortic valve. | Not Posted | 3-6 months, 1 year post-implant | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Effective Orifice Area Index (EOAI) Through 1 Year Post-implant (Remaining Data From 29mm Valve Participants Not Required for Meeting Primary Outcomes) | Evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory for effective orifice area index (EOAI = EOA/BSA) Effective orifice area index is equal to the effective orifice area (EOA) in cm^2 divided by body surface area (BSA) in m^2. The achievement criterion for the effective orifice area index (EOAI) is defined to be ≥0.6 cm^2/m^2 12 months after the procedure. This criterion is in accordance with the definition of severe aortic stenosis in the American College of Cardiology (ACC) / American Heart Association (AHA) guidelines for the management of valvular heart disease. | Not Posted | 3-6 months, and 1 year post-implant | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Peak Pressure Gradient (mmHg) From Discharge up to 1 Year (Remaining Data From 29mm Valve Participants Not Required for Meeting Primary Outcomes) | Evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory. The peak pressure gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. | Not Posted | 3-6 months, and 1 year post-implant | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Mean Pressure Gradient (mmHg) Through 1 Year Post-implant (Remaining Data From 29mm Valve Participants Not Required for Meeting Primary Outcomes) | Evaluated by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The mean pressure gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. | Not Posted | 3-6 months, and 1 year post-implant | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Performance Index (L/Min) Through 1 Year Post-implant (Remaining Data From 29mm Valve Participants Not Required for Meeting Primary Outcomes) | Performance index (L/Min) measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The performance index is the measurement of the effective orifice area divided by the native orifice area. | Not Posted | 3-6 months, and 1 year post-implant | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Output (L/Min) Through 1 Year Post-implant (Remaining Data From 29mm Valve Participants Not Required for Meeting Primary Outcomes) | Cardiac output is the amount of blood pumped by the heart per minute. Evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory. | Not Posted | 3-6 months, and 1 year post-implant | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Index (L/Min/m^2) Through 1 Year Post-implant (Remaining Data From 29mm Valve Participants Not Required for Meeting Primary Outcomes) | Evaluated by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The cardiac index is an assessment of the cardiac output based on a patient's size measured by dividing the cardiac output by the patient's body's surface area. | Not Posted | 3-6 months, and 1 year post-implant | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Confirm the Effectiveness of the Model 400 Avalus Valve by Clinically Acceptable Hemodynamic Performance From Years 6 Through 12 Post-implant. | Long-term follow-up clinically acceptable hemodynamic performance defined as freedom from surgical explant and/or percutaneous valve-in-valve reintervention due to structural valve deterioration | Not Posted | Annually, years 6-12 post-implant | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Confirm the Effectiveness of the Model 400 Avalus Valve From Years 6 - 12 Post-implant by Freedom From Valve-related Death | Not Posted | Annually, years 6 though 12 post-implant | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Confirm the Effectiveness of the Model 400 Avalus Valve From Years 6 - 12 Post-implant by Freedom From All-cause Mortality | For time-to-event outcomes, Kaplan-Meier (actuarial) analysis of the event-free rate performed annually through twelve years. | Not Posted | Annually, years 6 though 12 post-implant | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Confirm the Effectiveness of the Model 400 Avalus Valve From Years 6 - 12 Post-implant by Change in NYHA Functional Classification Status From Baseline | Not Posted | Annually, years 6 though 12 post-implant | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Effective Orifice Area Through 12 Years Post-procedure | Evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory. The effective orifice area (EOA) is measured as the minimal cross-sectional area of the blood flow downstream of the aortic valve. | Not Posted | Annually, years 6 though 12 post-implant | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Effective Orifice Area Index (EOAI) Through 12 Years Post-implant | Evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory for effective orifice area index (EOAI = EOA/BSA) Effective orifice area index is equal to the effective orifice area (EOA) in cm^2 divided by body surface area (BSA) in m^2. The achievement criterion for the effective orifice area index (EOAI) is defined to be ≥0.6 cm^2/m^2 12 months after the procedure. This criterion is in accordance with the definition of severe aortic stenosis in the American College of Cardiology (ACC) / American Heart Association (AHA) guidelines for the management of valvular heart disease. | Not Posted | Annually, years 6 though 12 post-implant | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to the Peak Pressure Gradient (mmHg) up to 12 Years Post-implant | Evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory. The peak pressure gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. | Not Posted | Annually, years 6 though 12 post-implant | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Mean Pressure Gradient (mmHg) Through 12 Years Post-implant | Evaluated by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The mean pressure gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. | Not Posted | Annually, years 6 though 12 post-implant | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Performance Index (L/Min) Through 12 Years Post-implant | Performance index (L/Min) measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The performance index is the measurement of the effective orifice area divided by the native orifice area. | Not Posted | Annually, years 6 though 12 post-implant | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Output (L/Min) Through 12 Years Post-implant | Cardiac output is the amount of blood pumped by the heart per minute. Evaluated by transthoracic echocardiography technique and assessed by an independent core laboratory. | Not Posted | Annually, years 6 though 12 post-implant | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Confirm the Effectiveness of the Model 400 Avalus Valve With Regard to Cardiac Index (L/Min/m^2) Through 12 Years Post-implant | Evaluated by transthoracic echocardiography technique and will be assessed by an independent core laboratory. The cardiac index is an assessment of the cardiac output based on a patient's size measured by dividing the cardiac output by the patient's body's surface area. | Not Posted | Annually, years 6 though 12 post-implant | Participants |
Site reported adverse events and serious adverse events data collected from implant through 1 year.
Site reported events for a minimum of 15 subjects per valve size through 1 year post-implant.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Medtronic Avalus Valve (All Valve Sizes) | All participants implanted with the with Medtronic Avalus Valve (sized 17mm - 29mm) from procedure through 1 year. | 170 | 1,132 | 638 | 1,132 | 1,105 | 1,132 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemias Haemolytic Immune | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Anaemias Nec | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Bleeding Tendencies | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Coagulopathies | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Haemolyses Nec | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Leukocytoses Nec | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Leukopenias Nec | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Spleen Disorders | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Thrombocytopenias | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Cardiac Conduction Disorders | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Cardiac Disorders Nec | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Cardiomyopathies | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Coronary Artery Disorders Nec | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Heart Failures Nec | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Ischaemic Coronary Artery Disorders | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Left Ventricular Failures | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Mitral Valvular Disorders | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Myocardial Disorders Nec | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Noninfectious Pericarditis | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Pericardial Disorders Nec | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Rate And Rhythm Disorders Nec | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Supraventricular Arrhythmias | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Tricuspid Valvular Disorders | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Ventricular Arrhythmias And Cardiac Arrest | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Cardiac Septal Defects Congenital | Congenital, familial and genetic disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Inner Ear Signs And Symptoms | Ear and labyrinth disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Thyroid Disorders Nec | Endocrine disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Optic Nerve Bleeding And Vascular Disorders | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Retinal Structural Change, Deposit And Degeneration | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Visual Impairment And Blindness (Excl Colour Blindness) | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Acute And Chronic Pancreatitis | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Anal And Rectal Disorders Nec | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Anal And Rectal Ulcers And Perforation | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Benign Neoplasms Gastrointestinal (Excl Oral Cavity) | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Colitis (Excl Infective) | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Diaphragmatic Hernias | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Diarrhoea (Excl Infective) | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Diverticula | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Duodenal And Small Intestinal Stenosis And Obstruction | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Duodenal Ulcers And Perforation | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Gastric And Oesophageal Haemorrhages | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Gastritis (Excl Infective) | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Gastrointestinal Atonic And Hypomotility Disorders Nec | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Gastrointestinal Signs And Symptoms Nec | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Gastrointestinal Stenosis And Obstruction Nec | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Gastrointestinal Ulcers And Perforation, Site Unspecified | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Gastrointestinal Vascular Occlusion And Infarction | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Inguinal Hernias | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Intestinal Haemorrhages | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Non-Mechanical Ileus | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Non-Site Specific Gastrointestinal Haemorrhages | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Peritoneal And Retroperitoneal Disorders | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Cardiac Complications Associated With Device | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Complications Associated With Device Nec | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Death And Sudden Death | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Febrile Disorders | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| General Signs And Symptoms Nec | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Healing Abnormal Nec | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Hernias Nec | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Oedema Nec | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Pain And Discomfort Nec | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Vascular Complications Associated With Device | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Cholecystitis And Cholelithiasis | Hepatobiliary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Cholestasis And Jaundice | Hepatobiliary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Hepatic And Hepatobiliary Disorders Nec | Hepatobiliary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Hepatic Failure And Associated Disorders | Hepatobiliary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Obstructive Bile Duct Disorders (Excl Neoplasms) | Hepatobiliary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Structural And Other Bile Duct Disorders | Hepatobiliary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Allergies To Foods, Food Additives, Drugs And Other Chemicals | Immune system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Anaphylactic And Anaphylactoid Responses | Immune system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Abdominal And Gastrointestinal Infections | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Bacterial Infections Nec | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Bone And Joint Infections | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Cardiac Infections | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Clostridia Infections | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Coronavirus Infections | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Fungal Infections Nec | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Herpes Viral Infections | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Infections Nec | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Lower Respiratory Tract And Lung Infections | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Sepsis, Bacteraemia, Viraemia And Fungaemia Nec | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Streptococcal Infections | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infections | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Urinary Tract Infections | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Vascular Infections | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Viral Infections Nec | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Abdominal And Gastrointestinal Injuries Nec | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Anaesthetic And Allied Procedural Complications | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Bone And Joint Injuries Nec | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Cardiac And Vascular Procedural Complications | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Cardiovascular Injuries | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Cerebral Injuries Nec | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Eye Injuries Nec | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Gastrointestinal And Hepatobiliary Procedural Complications | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Limb Fractures And Dislocations | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Medication Errors, Product Use Errors And Issues Nec | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Nerve Injuries Nec | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Non-Site Specific Injuries Nec | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Non-Site Specific Procedural Complications | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Respiratory Tract And Thoracic Cavity Procedural Complications | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Site Specific Injuries Nec | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Skin Injuries Nec | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Spinal Fractures And Dislocations | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Thoracic Cage Fractures And Dislocations | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Urinary Tract Procedural Complications | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Carbohydrate Tolerance Analyses (Incl Diabetes) | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Cardiac Function Diagnostic Procedures | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Coagulation And Bleeding Analyses | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Mineral And Electrolyte Analyses | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Protein Analyses Nec | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Red Blood Cell Analyses | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Renal Function Analyses | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Respiratory Tract And Thoracic Histopathology Procedures | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Skeletal And Cardiac Muscle Analyses | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Vascular Tests Nec (Incl Blood Pressure) | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| White Blood Cell Analyses | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Disorders Of Purine Metabolism | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Hyperglycaemic Conditions Nec | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Metabolic Acidoses (Excl Diabetic Acidoses) | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Sodium Imbalance | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Total Fluid Volume Decreased | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Total Fluid Volume Increased | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Cartilage Disorders | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Joint Related Disorders Nec | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Muscle Weakness Conditions | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Musculoskeletal And Connective Tissue Conditions Nec | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Musculoskeletal And Connective Tissue Pain And Discomfort | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Myopathies | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Osteoarthropathies | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Spine And Neck Deformities | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Bladder Neoplasms Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Breast And Nipple Neoplasms Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Central Nervous System Neoplasms Malignant Nec | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Endocrine Neoplasms Malignant And Unspecified Nec | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Female Reproductive Neoplasms Unspecified Malignancy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Gallbladder Neoplasms Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Laryngeal Neoplasms Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Leukaemias Acute Myeloid | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Lower Gastrointestinal Neoplasms Benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Myelodysplastic Syndromes | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Neoplasms Malignant Site Unspecified Nec | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Prostatic Neoplasms Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Renal Neoplasms Benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Renal Neoplasms Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Urinary Tract Neoplasms Unspecified Malignancy Nec | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Acute Polyneuropathies | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Central Nervous System Haemorrhages And Cerebrovascular Accidents | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Central Nervous System Vascular Disorders Nec | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Coordination And Balance Disturbances | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Dementia (Excl Alzheimer's Type) | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Disturbances In Consciousness Nec | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Encephalopathies Nec | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Encephalopathies Toxic And Metabolic | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Headaches Nec | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Hydrocephalic Conditions | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Increased Intracranial Pressure Disorders | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Lumbar Spinal Cord And Nerve Root Disorders | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Neurological Signs And Symptoms Nec | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Neuromuscular Disorders Nec | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Parkinson's Disease And Parkinsonism | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Peripheral Neuropathies Nec | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Seizures And Seizure Disorders Nec | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Spinal Cord And Nerve Root Disorders Nec | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Structural Brain Disorders Nec | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Transient Cerebrovascular Events | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Tremor (Excl Congenital) | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Device Incompatibility Issues | Product Issues | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Device Issues Nec | Product Issues | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Device Malfunction Events Nec | Product Issues | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Anxiety Symptoms | Psychiatric disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Confusion And Disorientation | Psychiatric disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Delusional Symptoms | Psychiatric disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Depressive Disorders | Psychiatric disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Mental Disorders Nec | Psychiatric disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Substance Related And Addictive Disorders | Psychiatric disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Bladder And Urethral Symptoms | Renal and urinary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Nephritis Nec | Renal and urinary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Renal Disorders Nec | Renal and urinary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Renal Failure And Impairment | Renal and urinary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Renal Lithiasis | Renal and urinary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Renal Obstructive Disorders | Renal and urinary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Urinary Abnormalities | Renal and urinary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Testicular And Epididymal Disorders Nec | Reproductive system and breast disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Breathing Abnormalities | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Bronchospasm And Obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Conditions Associated With Abnormal Gas Exchange | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Coughing And Associated Symptoms | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Lower Respiratory Tract Inflammatory And Immunologic Conditions | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Lower Respiratory Tract Signs And Symptoms | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Mediastinal Disorders | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Nasal Disorders Nec | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Parenchymal Lung Disorders Nec | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Pneumothorax And Pleural Effusions Nec | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Pulmonary Oedemas | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Pulmonary Thrombotic And Embolic Conditions | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Respiratory Failures (Excl Neonatal) | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Respiratory Tract Disorders Nec | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Dermal And Epidermal Conditions Nec | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Rashes, Eruptions And Exanthems Nec | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Skin Injuries And Mechanical Dermatoses | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Skin Preneoplastic Conditions Nec | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Cardiac Device Therapeutic Procedures | Surgical and medical procedures | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Cardiac Therapeutic Procedures Nec | Surgical and medical procedures | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Gastrointestinal Therapeutic Procedures Nec | Surgical and medical procedures | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Therapeutic Procedures Nec | Surgical and medical procedures | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Aortic Aneurysms And Dissections | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Aortic Necrosis And Vascular Insufficiency | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Circulatory Collapse And Shock | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Haemorrhages Nec | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Lymphangiopathies | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Non-Site Specific Embolism And Thrombosis | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Non-Site Specific Necrosis And Vascular Insufficiency Nec | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Non-Site Specific Vascular Disorders Nec | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Peripheral Embolism And Thrombosis | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Peripheral Vascular Disorders Nec | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Site Specific Necrosis And Vascular Insufficiency Nec | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Site Specific Vascular Disorders Nec | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Vascular Hypertensive Disorders Nec | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Vascular Hypotensive Disorders | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemias Nec | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Leukocytoses Nec | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Thrombocytopenias | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Cardiac Conduction Disorders | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Heart Failures Nec | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Pericardial Disorders Nec | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Supraventricular Arrhythmias | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Tricuspid Valvular Disorders | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Ventricular Arrhythmias And Cardiac Arrest | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Gastrointestinal Atonic And Hypomotility Disorders Nec | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Nausea And Vomiting Symptoms | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Oedema Nec | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Lower Respiratory Tract And Lung Infections | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Urinary Tract Infections | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Gastrointestinal And Hepatobiliary Procedural Complications | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Non-Site Specific Procedural Complications | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Physical Examination Procedures And Organ System Status | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Electrolyte Imbalance Nec | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Hyperglycaemic Conditions Nec | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Potassium Imbalance | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Total Fluid Volume Increased | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Musculoskeletal And Connective Tissue Pain And Discomfort | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Neurological Signs And Symptoms Nec | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Confusion And Disorientation | Psychiatric disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Bladder And Urethral Symptoms | Renal and urinary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Renal Failure And Impairment | Renal and urinary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Breathing Abnormalities | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Parenchymal Lung Disorders Nec | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Pneumothorax And Pleural Effusions Nec | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Pulmonary Oedemas | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Respiratory Failures (Excl Neonatal) | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Vascular Hypertensive Disorders Nec | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Vascular Hypotensive Disorders | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
Within 60 days of receipt Medtronic (MDT) will verify presence of Confidential Information (CI) & won't censor or interfere with presentation/conclusions except to protect CI (other than Study Data) & its rights in patentable or copyrightable materials, & check technical accuracy of MDT data. If told by MDT that Publication contains CI or technical errors of MDT data, PI will make requested changes before publishing/presenting. PI will delay publication up to 90 more days, if requested.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessica Halverson, Director of Clinical Research | Medtronic | (800) 633-8766 | rsperigonpivotaltrial@medtronic.com |
| Prot_003.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 26, 2022 | Apr 10, 2024 | SAP_004.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 4, 2015 | Aug 25, 2017 | ICF_002.pdf |
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| United States |
|
| Title | Measurements |
|---|---|
|
| NYHA Class III |
|
| NYHA Class IV |
|
| Valve- related death |
|
| Thromboembolism |
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| Valve thrombosis |
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| All hemorrhage |
|
| Major hemorrhage |
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| All paravalvular leak |
|
| Major paravalvular leak |
|
| Endocarditis |
|
| Hemolysis |
|
| Non-structural valve dysfunction |
|
| Structural valve deterioration |
|
| Severe hemodynamic dysfunction - indeterminate or evolving cause |
|
| Reintervention |
|
| Explant |
|
| OG001 |
| Medtronic Avalus Valve 21mm |
Effectiveness evaluation for participants implanted with the 21mm Medtronic Avalus Valve |
| OG002 | Medtronic Avalus Valve 23mm | Effectiveness evaluation for participants implanted with the 23mm Medtronic Avalus Valve |
| OG003 | Medtronic Avalus Valve 25mm | Effectiveness evaluation for participants implanted with the 25mm Medtronic Avalus Valve |
| OG004 | Medtronic Avalus Valve 27mm | Effectiveness evaluation for participants implanted with the 27mm Medtronic Avalus Valve |
| OG005 | Medtronic Avalus Valve 29mm | Effectiveness evaluation for participants implanted with the 29mm Medtronic Avalus Valve |
| OG006 | Medtronic Avalus Valve (17mm - 29mm) | Effectiveness evaluation for participants implanted with the with Medtronic Avalus Valves sized 17mm - 29mm. One subject implanted with 17mm Avalus Valve included only in composite results to protect privacy. |
|
|
Effectiveness evaluation for participants implanted with the 25mm Medtronic Avalus Valve |
| OG004 | Medtronic Avalus Valve 27mm | Effectiveness evaluation for participants implanted with the 27mm Medtronic Avalus Valve |
| OG005 | Medtronic Avalus Valve 29mm | Effectiveness evaluation for participants implanted with the 29mm Medtronic Avalus Valve |
| OG006 | Medtronic Avalus Valve (17mm - 29mm) | Effectiveness evaluation for participants implanted with the with Medtronic Avalus Valves sized 17mm - 29mm. One subject implanted with 17mm Avalus Valve included only in composite results to protect privacy. |
|
|
Effectiveness evaluation for participants implanted with the 23mm Medtronic Avalus Valve |
| OG003 | Medtronic Avalus Valve 25mm | Effectiveness evaluation for participants implanted with the 25mm Medtronic Avalus Valve |
| OG004 | Medtronic Avalus Valve 27mm | Effectiveness evaluation for participants implanted with the 27mm Medtronic Avalus Valve |
| OG005 | Medtronic Avalus Valve 29mm | Effectiveness evaluation for participants implanted with the 29mm Medtronic Avalus Valve |
| OG006 | Medtronic Avalus Valve (17mm - 29mm) | Effectiveness evaluation for participants implanted with the with Medtronic Avalus Valves sized 17mm - 29mm. One subject implanted with 17mm Avalus Valve included only in composite results to protect privacy. |
|
|
Effectiveness evaluation for participants implanted with the 25mm Medtronic Avalus Valve |
| OG004 | Medtronic Avalus Valve 27mm | Effectiveness evaluation for participants implanted with the 27mm Medtronic Avalus Valve |
| OG005 | Medtronic Avalus Valve 29mm | Effectiveness evaluation for participants implanted with the 29mm Medtronic Avalus Valve |
| OG006 | Medtronic Avalus Valve (17mm - 29mm) | Effectiveness evaluation for participants implanted with the with Medtronic Avalus Valves sized 17mm - 29mm. One subject implanted with 17mm Avalus Valve included only in composite results to protect privacy. |
|
|
Effectiveness evaluation for participants implanted with the 25mm Medtronic Avalus Valve |
| OG004 | Medtronic Avalus Valve 27mm | Effectiveness evaluation for participants implanted with the 27mm Medtronic Avalus Valve |
| OG005 | Medtronic Avalus Valve 29mm | Effectiveness evaluation for participants implanted with the 29mm Medtronic Avalus Valve |
| OG006 | Medtronic Avalus Valve (17mm - 29mm) | Effectiveness evaluation for participants implanted with the with Medtronic Avalus Valves sized 17mm - 29mm. One subject implanted with 17mm Avalus Valve included only in composite results to protect privacy. |
|
|
Effectiveness evaluation for participants implanted with the 25mm Medtronic Avalus Valve |
| OG004 | Medtronic Avalus Valve 27mm | Effectiveness evaluation for participants implanted with the 27mm Medtronic Avalus Valve |
| OG005 | Medtronic Avalus Valve 29mm | Effectiveness evaluation for participants implanted with the 29mm Medtronic Avalus Valve |
| OG006 | Medtronic Avalus Valve (17mm - 29mm) | Effectiveness evaluation for participants implanted with the with Medtronic Avalus Valves sized 17mm - 29mm. One subject implanted with 17mm Avalus Valve included only in composite results to protect privacy. |
|
|
Effectiveness evaluation for participants implanted with the 25mm Medtronic Avalus Valve |
| OG004 | Medtronic Avalus Valve 27mm | Effectiveness evaluation for participants implanted with the 27mm Medtronic Avalus Valve |
| OG005 | Medtronic Avalus Valve 29mm | Effectiveness evaluation for participants implanted with the 29mm Medtronic Avalus Valve |
| OG006 | Medtronic Avalus Valve (17mm - 29mm) | Effectiveness evaluation for participants implanted with the with Medtronic Avalus Valves sized 17mm - 29mm. One subject implanted with 17mm Avalus Valve included only in composite results to protect privacy. |
|
|
| Medtronic Avalus Valve 25mm |
Effectiveness evaluation for participants implanted with the 25mm Medtronic Avalus Valve |
| OG004 | Medtronic Avalus Valve 27mm | Effectiveness evaluation for participants implanted with the 27mm Medtronic Avalus Valve |
| OG005 | Medtronic Avalus Valve 29mm | Effectiveness evaluation for participants implanted with the 29mm Medtronic Avalus Valve |
| OG006 | Medtronic Avalus Valve (17mm - 29mm) | Effectiveness evaluation for participants implanted with the with Medtronic Avalus Valves sized 17mm - 29mm. One subject implanted with 17mm Avalus Valve included only in composite results to protect privacy. |
|
|
| Improved 2 Classes |
|
| Improved 1 Class |
|
| No Change |
|
| Worsened 1 Class |
|
| Worsened 2 Classes |
|
| Worsened 3 Classes |
|
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