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The purpose of this clinical investigation is to confirm that the safety and performance of the EDWARDS INTUITY Valve System.
This is a two-phase, non-randomized, prospective, single arm, multi-center clinical investigation. Each subject in Phase 1 and Phase 2 is consented for a period of 5 years. All subjects will be assessed for clinical follow-up at the following intervals: Discharge, 1 month, 3 months, 1 year and annually thereafter until 5 years of follow-up is achieved per subject.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Valve | Other | Subjects act as own control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aortic Valve Replacement with EDWARDS INTUITY Valve System | Device | Aortic Valve bioprosthesis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Early Adverse Events | Number of early adverse events occurring within 30 days of procedure divided by the total number of enrolled subjects times 100. | Events occuring within 30 days of procedure |
| Percent of Late Adverse Events | Number of late adverse events divided by the total number of late patient years times 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event). | Events occurring >= 31 days and up through 5 years post-implant |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subject's With Device Technical Success | Device technical success is defined as the successful delivery and deployment of one bioprosthesis with one delivery system with a maximum of two attempts. | At time of surgery, an average of 3 hours |
| Number of Subject's With Procedural Success |
Criteria:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prof Axel Haverich | MHH Hannover | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AKH Vienna-Allgemeines Krankenhaus der Stadt Wien; University Vienna | Vienna | 1090 | Austria | |||
| Kerchoff Klinik-Bad Nauheim |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28453629 | Result | Laufer G, Haverich A, Andreas M, Mohr FW, Walther T, Shrestha M, Rahmanian P, Holzhey D, Roth M, Schmitz C, Schramm R, Giot C, Wahlers TCW. Long-term outcomes of a rapid deployment aortic valve: data up to 5 years. Eur J Cardiothorac Surg. 2017 Aug 1;52(2):281-287. doi: 10.1093/ejcts/ezx103. | |
| 25218544 | Result |
| Label | URL |
|---|---|
| New York Heart Association Classification | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | INTUITY Aortic Valve and INTUITY Delivery System | The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The outcome is reported for subjects who received the EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB where data is available.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | INTUITY Aortic Valve and INTUITY Delivery System | The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent of Early Adverse Events | Number of early adverse events occurring within 30 days of procedure divided by the total number of enrolled subjects times 100. | The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available. | Posted | Number | Percentage of subjects | Events occuring within 30 days of procedure |
|
Events occurring from baseline through five years post-implant
The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.
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 | INTUITY Aortic Valve and INTUITY Delivery System | The EDWARDS INTUITY Aortic Valve models 8300ACA and 8300ACB, and the EDWARDS INTUITY Delivery System models 8300DCA and 8300DCB are intended for use in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Other | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Other | General disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrey Nersesov, Sr. Director of Clinical Affairs, Surgical Structural Heart | Edwards Lifesciences, LLC | 949-250-2500 | 0225 | Andrey_Nersesov@edwards.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 15, 2011 | Jan 3, 2020 | Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Procedure success is defined as device technical success followed by the absence of adverse events requiring device reoperation, requiring implantation of permanent pacemaker, or subject death. |
| Discharge(an average of 13 days) or 10 days post-implant, whichever comes first |
| Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath). Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath). Class III. Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV. Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases. | 1 Month, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant |
| Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time | The EQ-5D is a standardized questionnaire that asks subjects to rate themselves (no problems, some problems, extreme problems) on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale is indexed and ranges from a minimum of 0.275 and a maximum of 1.000. A lower number indicates the participants experiences more problems and a higher number indicates the participants experiences fewer problems. | Baseline, 3 Months, and 1 Year post-implant |
| Subject's Average Mean Systolic Gradient Measurements Over Time. | Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. Mean gradient values depend on the size and type of valve. | Discharge (an average of 13 days), 1 Month, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant |
| Subject's Average Effective Orifice Area Measurements Over Time. | Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve. Effective orifice area is evaluated by echocardiography over time. | Discharge (an average of 13 days), 1 Month, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant |
| Subject's Amount of Aortic Valvular Regurgitation Over Time | Aortic valvular regurgitation occurs when the aortic valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Aortic valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation. | Discharge (an average of 13 days), 1 Month, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant |
| Subject's Average White Blood Cell Count Measurement Over Time. | Laboratory analysis of White Blood Cell Count on blood drawn from subject; WBC fight infection. | Baseline, 3 Months, 1 Year, and 5 Years post-implant |
| Subject's Average Red Blood Cells Count Over Time. | Laboratory Analysis of Red Blood Cell Count on blood drawn from subjects; RBC carry oxygen. | Baseline, 3 Months, 1 Year, and 5 Years post-implant |
| Subject's Average Hemoglobin Count Over Time. | Laboratory Analysis of Hemoglobin Count on blood drawn from subjects. Hemoglobin is an oxygen-carrying protein in red blood cells. | Baseline, 3 Months, 1 Year, and 5 Years post-implant |
| Subject's Average Hematocrit Percentage Over Time. | Laboratory Analysis of Hematocrit Percentage on blood drawn from subjects. Hematocrit is the proportion of red blood cells to the fluid component (plasma) in the blood. | Baseline, 3 Months, 1 Year, and 5 Years post-implant |
| Subject's Average Platelet Count Over Time. | Laboratory Analysis of Platelet Count on blood drawn from subjects; platelets help with blood clotting. | Baseline, 3 Months, 1 Year, and 5 Years post-implant |
| Subject's Average Reticulocytes Percentage Over Time. | Reticulocytes are immature red blood cells; a reticulocyte blood test measures the amount of these cells in the blood. | Baseline, 3 Months, 1 Year, and 5 Years post-implant |
| Subject's Average Haptoglobin Measurement Over Time. | Laboratory Analysis of Haptoglobin on blood drawn from subjects; Haptoglobin is a protein produced by the liver. | Baseline, 3 Months, 1 Year, and 5 Years post-implant |
| Subject's Average Serum LDH Measurement Over Time. | The lactate dehydrogenase (LDH) test looks for signs of damage to the body's tissues. | Baseline, 3 Months, 1 Year, and 5 Years post-implant |
| Bad Nauheim |
| 61231 |
| Germany |
| Herzzentrum Uniklink Koln-Klinik und Poliklinik fur Herz und Thoraxzchirurgie | Cologne | 50937 | Germany |
| MHH-Medizinische Hoschschule Hannover | Hanover | 30625 | Germany |
| University Leipzig: Herzzentrum Leipzig Gmbh | Leipzig | 04289 | Germany |
| Klinikum der Universitat Muchen-Grosshadern; Clinic at the University of Munich | Munich | 81377 | Germany |
| Haverich A, Wahlers TC, Borger MA, Shrestha M, Kocher AA, Walther T, Roth M, Misfeld M, Mohr FW, Kempfert J, Dohmen PM, Schmitz C, Rahmanian P, Wiedemann D, Duhay FG, Laufer G. Three-year hemodynamic performance, left ventricular mass regression, and prosthetic-patient mismatch after rapid deployment aortic valve replacement in 287 patients. J Thorac Cardiovasc Surg. 2014 Dec;148(6):2854-60. doi: 10.1016/j.jtcvs.2014.07.049. Epub 2014 Aug 1. |
| 23058665 | Result | Kocher AA, Laufer G, Haverich A, Shrestha M, Walther T, Misfeld M, Kempfert J, Gillam L, Schmitz C, Wahlers TC, Wippermann J, Mohr FW, Roth M, Skwara A, Rahmanian P, Wiedemann D, Borger MA. One-year outcomes of the Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve (TRITON) trial: a prospective multicenter study of rapid-deployment aortic valve replacement with the EDWARDS INTUITY Valve System. J Thorac Cardiovasc Surg. 2013 Jan;145(1):110-5; discussion 115-6. doi: 10.1016/j.jtcvs.2012.07.108. Epub 2012 Oct 8. |
| 29912142 | Result | Wahlers TCW, Andreas M, Rahmanian P, Candolfi P, Zemanova B, Giot C, Ferrari E, Laufer G. Outcomes of a Rapid Deployment Aortic Valve Versus Its Conventional Counterpart: A Propensity-Matched Analysis. Innovations (Phila). 2018 May/Jun;13(3):177-183. doi: 10.1097/IMI.0000000000000509. |
| 38334371 | Derived | Alaklabi AM, Abdul Rab S, Sabbah BN, Maklad AE, Dokollari A, Van den Eynde J, Pompeu Sa M, Arjomandi Rad A, Ahsan MR, Fatehi Hassanabad A. Innovations in Aortic Valve Replacement: A Comprehensive Overview of the Intuity Rapid Deployment Valve. Cardiol Rev. 2026 Jan-Feb 01;34(1):30-39. doi: 10.1097/CRD.0000000000000657. Epub 2024 Feb 9. |
| Subjects declined to return for followup |
|
| Consented but did not receive device |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | Percent of Late Adverse Events | Number of late adverse events divided by the total number of late patient years times 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event). | The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available. | Posted | Number | Percentage of late adverse events | Events occurring >= 31 days and up through 5 years post-implant |
|
|
|
| Other Pre-specified | Number of Subject's With Device Technical Success | Device technical success is defined as the successful delivery and deployment of one bioprosthesis with one delivery system with a maximum of two attempts. | This outcome is reported for enrolled subjects where data is available. Subjects were considered enrolled after meeting all the enrollment criteria, signing the informed consent, and after the surgeon sized the aortic annulus, and determined that the bioprosthesis could be implanted. | Posted | Count of Participants | Participants | At time of surgery, an average of 3 hours |
|
|
|
| Other Pre-specified | Number of Subject's With Procedural Success | Procedure success is defined as device technical success followed by the absence of adverse events requiring device reoperation, requiring implantation of permanent pacemaker, or subject death. | This outcome is reported for enrolled subjects where data is available. Subjects were considered enrolled after meeting all the enrollment criteria, signing the informed consent, and after the surgeon sized the aortic annulus, and determined that the bioprosthesis could be implanted. | Posted | Count of Participants | Participants | Discharge(an average of 13 days) or 10 days post-implant, whichever comes first |
|
|
|
| Other Pre-specified | Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline | The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath). Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath). Class III. Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV. Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases. | The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available. | Posted | Count of Participants | Participants | 1 Month, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant |
|
|
|
| Other Pre-specified | Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time | The EQ-5D is a standardized questionnaire that asks subjects to rate themselves (no problems, some problems, extreme problems) on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale is indexed and ranges from a minimum of 0.275 and a maximum of 1.000. A lower number indicates the participants experiences more problems and a higher number indicates the participants experiences fewer problems. | The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 3 Months, and 1 Year post-implant |
|
|
|
| Other Pre-specified | Subject's Average Mean Systolic Gradient Measurements Over Time. | Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. Mean gradient values depend on the size and type of valve. | The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available. | Posted | Mean | Standard Deviation | mmHg | Discharge (an average of 13 days), 1 Month, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant |
|
|
|
| Other Pre-specified | Subject's Average Effective Orifice Area Measurements Over Time. | Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve. Effective orifice area is evaluated by echocardiography over time. | The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available. | Posted | Mean | Standard Deviation | Centimeters Squared | Discharge (an average of 13 days), 1 Month, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant |
|
|
|
| Other Pre-specified | Subject's Amount of Aortic Valvular Regurgitation Over Time | Aortic valvular regurgitation occurs when the aortic valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Aortic valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation. | The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available. | Posted | Count of Participants | Participants | Discharge (an average of 13 days), 1 Month, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant |
|
|
|
| Other Pre-specified | Subject's Average White Blood Cell Count Measurement Over Time. | Laboratory analysis of White Blood Cell Count on blood drawn from subject; WBC fight infection. | The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available. | Posted | Mean | Standard Deviation | 10^3 cells/microliters | Baseline, 3 Months, 1 Year, and 5 Years post-implant |
|
|
|
| Other Pre-specified | Subject's Average Red Blood Cells Count Over Time. | Laboratory Analysis of Red Blood Cell Count on blood drawn from subjects; RBC carry oxygen. | The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available. | Posted | Mean | Standard Deviation | 10^6 cells/microliters | Baseline, 3 Months, 1 Year, and 5 Years post-implant |
|
|
|
| Other Pre-specified | Subject's Average Hemoglobin Count Over Time. | Laboratory Analysis of Hemoglobin Count on blood drawn from subjects. Hemoglobin is an oxygen-carrying protein in red blood cells. | The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available. | Posted | Mean | Standard Deviation | g/dl | Baseline, 3 Months, 1 Year, and 5 Years post-implant |
|
|
|
| Other Pre-specified | Subject's Average Hematocrit Percentage Over Time. | Laboratory Analysis of Hematocrit Percentage on blood drawn from subjects. Hematocrit is the proportion of red blood cells to the fluid component (plasma) in the blood. | The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available. | Posted | Mean | Standard Deviation | percentage of red blood cells | Baseline, 3 Months, 1 Year, and 5 Years post-implant |
|
|
|
| Other Pre-specified | Subject's Average Platelet Count Over Time. | Laboratory Analysis of Platelet Count on blood drawn from subjects; platelets help with blood clotting. | The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available. | Posted | Mean | Standard Deviation | 10^3 platelets per microliter | Baseline, 3 Months, 1 Year, and 5 Years post-implant |
|
|
|
| Other Pre-specified | Subject's Average Reticulocytes Percentage Over Time. | Reticulocytes are immature red blood cells; a reticulocyte blood test measures the amount of these cells in the blood. | The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available. | Posted | Mean | Standard Deviation | percentage of reticulocytes | Baseline, 3 Months, 1 Year, and 5 Years post-implant |
|
|
|
| Other Pre-specified | Subject's Average Haptoglobin Measurement Over Time. | Laboratory Analysis of Haptoglobin on blood drawn from subjects; Haptoglobin is a protein produced by the liver. | The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available. | Posted | Mean | Standard Deviation | g/L | Baseline, 3 Months, 1 Year, and 5 Years post-implant |
|
|
|
| Other Pre-specified | Subject's Average Serum LDH Measurement Over Time. | The lactate dehydrogenase (LDH) test looks for signs of damage to the body's tissues. | The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available. | Posted | Mean | Standard Deviation | U/L | Baseline, 3 Months, 1 Year, and 5 Years post-implant |
|
|
|
| 51 |
| 287 |
| 233 |
| 287 |
| 189 |
| 287 |
| Pulmonary - Pleural Effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Infection - Other | Infections and infestations | Systematic Assessment |
|
| Cardiac - Other | Cardiac disorders | Systematic Assessment |
|
| Gastrointestinal - Other | Gastrointestinal disorders | Systematic Assessment |
|
| Cardiac - Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
|
| Other - Anemia | General disorders | Systematic Assessment |
|
| Cardiac - Heart Failure | Cardiac disorders | Systematic Assessment |
|
| Cardiac - Other Arrhythmia | Cardiac disorders | Systematic Assessment |
|
| Cardiac - AV Block III | Cardiac disorders | Systematic Assessment |
|
| Embolic Event - Stroke | Cardiac disorders | Systematic Assessment |
|
| Infection - Local | Infections and infestations | Systematic Assessment |
|
| Infection - Pneumonia | Infections and infestations | Systematic Assessment |
|
| Renal - Renal Failure | Renal and urinary disorders | Systematic Assessment |
|
| Vascular - Other | Vascular disorders | Systematic Assessment |
|
| Bleeding - Gastrointestinal | Blood and lymphatic system disorders | Systematic Assessment |
|
| Pulmonary - Other | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Bleeding - Post-Procedural | Blood and lymphatic system disorders | Systematic Assessment |
|
| Bleeding - Other | Blood and lymphatic system disorders | Systematic Assessment |
|
| Cardiac - Hypertension | Cardiac disorders | Systematic Assessment |
|
| Pulmonary - Respiratory Dysfunction/Insufficiency | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Renal - Renal Dysfunction | Renal and urinary disorders | Systematic Assessment |
|
| Cardiac - Atrial Flutter | Cardiac disorders | Systematic Assessment |
|
| Cardiac - Pericardial Effusion | Cardiac disorders | Systematic Assessment |
|
| Embolic Event - TIA | Cardiac disorders | Systematic Assessment |
|
| Infection - Sternal Wound Infection | Infections and infestations | Systematic Assessment |
|
| Cardiac - Cardiac Arrest | Cardiac disorders | Systematic Assessment |
|
| Cardiac - Myocardial Infarction | Cardiac disorders | Systematic Assessment |
|
| Infection - Sepsis/Septicemia | Infections and infestations | Systematic Assessment |
|
| Cardiac - Angina, Stable | Cardiac disorders | Systematic Assessment |
|
| Pulmonary - Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Infection - Bacteremia | Infections and infestations | Systematic Assessment |
|
| Pulmonary - Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Renal - Other | Renal and urinary disorders | Systematic Assessment |
|
| Cardiac - Angina, Unstable | Cardiac disorders | Systematic Assessment |
|
| Bleeding - Anticoagulant Related | Blood and lymphatic system disorders | Systematic Assessment |
|
| Bleeding - Hematoma | Blood and lymphatic system disorders | Systematic Assessment |
|
| Bleeding - Pericardial Tamponade | Blood and lymphatic system disorders | Systematic Assessment |
|
| Cardiac - Bradycardia | Cardiac disorders | Systematic Assessment |
|
| Other - Allergic Reaction | General disorders | Systematic Assessment |
|
| Vascular - Deep Vein Thrombosis (DVT) | Cardiac disorders | Systematic Assessment |
|
| Infection - Endocarditis (Aortic Valve) | Infections and infestations | Systematic Assessment |
|
| Bleeding - Hemolysis | Blood and lymphatic system disorders | Systematic Assessment |
|
| Bleeding - Procedural | Blood and lymphatic system disorders | Systematic Assessment |
|
| Cardiac - Hypotension | Cardiac disorders | Systematic Assessment |
|
| Cardiac - Supraventricular Tachycardia (SVT) | Cardiac disorders | Systematic Assessment |
|
| Embolic Event - Other | Blood and lymphatic system disorders | Systematic Assessment |
|
| Embolic Event - Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hepatic - Other | Hepatobiliary disorders | Systematic Assessment |
|
| Multisystem Organ Failure | General disorders | Systematic Assessment |
|
| Valvular - Paravalvular Leak - Moderate | Cardiac disorders | Systematic Assessment |
|
| Bleeding - Intracranial | Blood and lymphatic system disorders | Systematic Assessment |
|
| Cardiac - Aortic Dissection - Type A | Cardiac disorders | Systematic Assessment |
|
| Cardiac - Aortic Dissection - Type B | Cardiac disorders | Systematic Assessment |
|
| Cardiac - AV Block II | Cardiac disorders | Systematic Assessment |
|
| Cardiac - Cardiogenic Shock | Cardiac disorders | Systematic Assessment |
|
| Cardiac - Pericardial Tamponade | Cardiac disorders | Systematic Assessment |
|
| Cardiac - Ventricular Fibrillation | Cardiac disorders | Systematic Assessment |
|
| Embolic Event - Peripheral Embolic Event | Cardiac disorders | Systematic Assessment |
|
| Hepatic - Liver Failure | Hepatobiliary disorders | Systematic Assessment |
|
| Infection - Endocarditis (Mitral Valve) | Infections and infestations | Systematic Assessment |
|
| Infection - Systemic | Infections and infestations | Systematic Assessment |
|
| Pulmonary - Atelectasis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pulmonary - Pulmonary Edema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pulmonary - Pulmonary Hypertension | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Valvular - Aortic Regurgitation - Moderate-Severe | Cardiac disorders | Systematic Assessment |
|
| Valvular - Mitral Regurgitation - Mild-Moderate | Cardiac disorders | Systematic Assessment |
|
| Valvular - Mitral Regurgitation - Moderate-Severe | Cardiac disorders | Systematic Assessment |
|
| Valvular - Other Mitral Valve | Cardiac disorders | Systematic Assessment |
|
| Valvular - Paravalvular Leak - Mild | Cardiac disorders | Systematic Assessment |
|
| Vascular - Vascular Access Site Complication | Cardiac disorders | Systematic Assessment |
|
| Infection - Other | Infections and infestations | Systematic Assessment |
|
| Cardiac - Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
|
| Gastrointestinal - Other | Gastrointestinal disorders | Systematic Assessment |
|
| Pulmonary - Pleural Effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Infection - Local | Infections and infestations | Systematic Assessment |
|
| Other - Anemia | General disorders | Systematic Assessment |
|
| Cardiac - BBB - Left Complete | Cardiac disorders | Systematic Assessment |
|
| Renal - Renal Dysfunction | Renal and urinary disorders | Systematic Assessment |
|
| Valvular - Mitral Regurgitation - Mild | Cardiac disorders | Systematic Assessment |
|
| Cardiac - Other | Cardiac disorders | Systematic Assessment |
|
| Cardiac - BBB - Left Partial | Cardiac disorders | Systematic Assessment |
|
| Cardiac - Other Arrhythmia | Cardiac disorders | Systematic Assessment |
|
| Infection - Pneumonia | Infections and infestations | Systematic Assessment |
|
| Pulmonary - Other | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Cardiac - Atrial Flutter | Cardiac disorders | Systematic Assessment |
|
| Infection - Sternal Wound Infection | Infections and infestations | Systematic Assessment |
|
| Renal - Other | Renal and urinary disorders | Systematic Assessment |
|
| Valvular - Aortic Regurgitation - Mild | Cardiac disorders | Systematic Assessment |
|
| Bleeding - Hematoma | Blood and lymphatic system disorders | Systematic Assessment |
|
| Bleeding - Other | Blood and lymphatic system disorders | Systematic Assessment |
|
| Cardiac - BBB - Right Complete | Cardiac disorders | Systematic Assessment |
|
| Infection - Bacteremia | Infections and infestations | Systematic Assessment |
|
| Vascular - Deep Vein Thrombosis (DVT) | Cardiac disorders | Systematic Assessment |
|
| Other - Allergic Reaction | General disorders | Systematic Assessment |
|
| Bleeding - Anticoagulant Related | Blood and lymphatic system disorders | Systematic Assessment |
|
| Cardiac - AV Block I | Cardiac disorders | Systematic Assessment |
|
| Cardiac - Bradycardia | Cardiac disorders | Systematic Assessment |
|
| Cardiac - Hypertension | Cardiac disorders | Systematic Assessment |
|
| Cardiac - Ventricular Tachycardia | Cardiac disorders | Systematic Assessment |
|
| Hepatic - Other | Gastrointestinal disorders | Systematic Assessment |
|
| Valvular - Aortic Stenosis - Moderate | Cardiac disorders | Systematic Assessment |
|
| Bleeding - Gastrointestinal | Blood and lymphatic system disorders | Systematic Assessment |
|
| Cardiac - AV Block III | Cardiac disorders | Systematic Assessment |
|
| Cardiac - Pericardial Effusion | Cardiac disorders | Systematic Assessment |
|
| Embolic Event - Other | Blood and lymphatic system disorders | Systematic Assessment |
|
| Embolic Event - Stroke | Blood and lymphatic system disorders | Systematic Assessment |
|
| Embolic Event - TIA | Blood and lymphatic system disorders | Systematic Assessment |
|
| Bleeding - Hemolysis | Blood and lymphatic system disorders | Systematic Assessment |
|
| Bleeding - Heparin Induced Thrombocytopenia (HITS) | Blood and lymphatic system disorders | Systematic Assessment |
|
| Cardiac - Angina, Stable | Cardiac disorders | Systematic Assessment |
|
| Cardiac - Heart Failure | Cardiac disorders | Systematic Assessment |
|
| Cardiac - Hypotension | Cardiac disorders | Systematic Assessment |
|
| Cardiac - Supraventricular Tachycardia (SVT) | Cardiac disorders | Systematic Assessment |
|
| Embolic Event - Peripheral Embolic Event | Blood and lymphatic system disorders | Systematic Assessment |
|
| Infection - Systemic | Infections and infestations | Systematic Assessment |
|
| Pulmonary - Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pulmonary - Pulmonary Hypertension | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pulmonary - Respiratory Dysfunction/Insufficiency | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pulmonary - Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Valvular - Aortic Regurgitation - Mild-Moderate | Cardiac disorders | Systematic Assessment |
|
| Valvular - Aortic Stenosis - Mild | Cardiac disorders | Systematic Assessment |
|
| Valvular - Aortic Stenosis - Severe | Cardiac disorders | Systematic Assessment |
|
| Valvular - Mitral Regurgitation - Moderate-Severe | Cardiac disorders | Systematic Assessment |
|
| Valvular - Other Mitral Valve | Cardiac disorders | Systematic Assessment |
|
| Valvular - Other Tricuspid Valve | Cardiac disorders | Systematic Assessment |
|
| Valvular - Paravalvular Leak - Mild/Moderate | Cardiac disorders | Systematic Assessment |
|
| Valvular - Paravalvular Leak - Moderate | Cardiac disorders | Systematic Assessment |
|
| Valvular - Paravalvular Leak - Trace/Trivial | Cardiac disorders | Systematic Assessment |
|
| Valvular - Structural Deterioration | Cardiac disorders | Systematic Assessment |
|
| Valvular - Tricuspid Regurgitation | Cardiac disorders | Systematic Assessment |
|
| Vascular - Other | Cardiac disorders | Systematic Assessment |
|
Publication of overall study results which have not been released requires written approval of Sponsor, but presentation of site-specific results can occur subject to review by Sponsor. Manuscripts will be submitted to Sponsor for review 60 days prior to submission of manuscript for publication/presentation. Sponsor may ask for a 90 day delay of submission of manuscripts for publication to protect proprietary information and filing of related patent applications.
| D014694 |
| Ventricular Outflow Obstruction |
| Title | Measurements |
|---|---|
|
| Valve Thrombosis |
|
| Major Bleeding |
|
| All Paravalvular Leak (OPC) |
|
| Hemolysis |
|
| Endocarditis |
|
| Structural Valve Deterioration |
|
| Reoperation |
|
| Explant |
|
| Valve Related AE |
|
| Worsened |
|
| 3 Months |
|
|
| 1 Year |
|
|
| 2 Years |
|
|
| 3 Years |
|
|
| 4 Years |
|
|
| 5 Years |
|
|
|
| 3 Months |
|
|
| 1 Year |
|
|
| 2 Years |
|
|
| 3 Years |
|
|
| 4 Years |
|
|
| 5 Years |
|
|
|
| 3 Months |
|
|
| 1 Year |
|
|
| 2 Years |
|
|
| 3 Years |
|
|
| 4 Years |
|
|
| 5 Years |
|
|
| +3 Moderate |
|
| +4 Severe |
|
| 1 Month |
|
|
| 3 Months |
|
|
| 1 Year |
|
|
| 2 Years |
|
|
| 3 Years |
|
|
| 4 Years |
|
|
| 5 Years |
|
|
|
| 1 Year |
|
|
| 5 Years |
|
|
|
| 1 Year |
|
|
| 5 Years |
|
|
|
| 1 Year |
|
|
| 5 Years |
|
|
|
| 1 Year |
|
|
| 5 Years |
|
|
|
| 1 Year |
|
|
| 5 Years |
|
|
|
| 1 Year |
|
|
| 5 Years |
|
|
|
| 1 Year |
|
|
| 5 Years |
|
|
|
| 1 Year |
|
|
| 5 Years |
|
|