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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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The purpose of this study is to evaluate the safety and effectiveness of the 17mm MDT-2215 aortic valve bioprosthesis.
This is a prospective, interventional, non-randomized, multi-center trial, with each site following a common protocol in Japan. A maximum of 20 subjects will be implanted at a maximum of 10 sites in Japan. The trial will include male and female patients of legal age to provide informed consent in Japan, requiring replacement for a diseased, damaged, or malfunctioning native or prosthetic aortic valve. Patients will be followed and assessed after implant for up to 5 years.
This clinical trial information was submitted voluntarily under the applicable law and therefore, certain submission deadlines may not apply. (that is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CRF 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act of 42 CRF 11.24 and 11.44.)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MDT-2215 | Experimental | 17mm MDT-2215 aortic valve bioprosthesis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 17mm MDT-2215 aortic valve bioprosthesis | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Changes in NYHA Classification From Baseline to 1 Year Post-procedure | Change in New York Heart Association (NYHA) functional classification from baseline to 1 year post-procedure will be evaluated. 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. | This outcome will be identified from measurement at baseline and 1 year. |
| Effective Orifice Area Index at Baseline and 1 Year Post-procedure | Effective Orifice Area Index (EOAI) at 1 year post-procedure will be evaluated. Effective Orifice Area Index (EOAI) in cm^2/m^2 EOAI = EOA/BSA Where: EOA is the effective orifice area in cm^2, and BSA is the body surface area in m^2 | This outcome will be measured at 1 year. |
| Number of Participants With Composite New York Heart Association (NYHA) Classification and Effective Orifice EOAI Endpoint Improvement From Baseline to 1 Year | Composite number of participants with NYHA change from baseline to 1 year post-procedure of 1 or greater and effective number of participants with effective EOAI 0.6cm^2/m^2 or greater at 1 year post implant will be evaluated. The objective is met if at least 60% of the subjects achieve the specified improvement in NYHA and EOAI. See Objective 1 for NYHA definition See Objective 2 for EOAI definition | This outcome will be identified from measurement at baseline and 1 year. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of NYHA Functional Classification for Participants From Baseline up to 5 Years | NYHA functional classification evaluation at baseline, discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years. Measure Description: Cardiac Disease with Functional Classes 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 provided
Inclusion Criteria:
Patient has severe 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:
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
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
In the opinion of the investigator, pre-operative imaging indicates the patient may be suitable for a 17mm size valve
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 MDT-2215 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
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
Patient is in NYHA Class I
Operative Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yutaka Okita, MD | Kobe University Hospital, Japan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chiba-Nishi General Hospital | Chiba | 270-2251 | Japan | |||
| Kobe University Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | MDT-2215 | 17mm MDT-2215 aortic valve bioprosthesis |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Data from 11 participants implanted with MDT-2215 17mm valve from 25 enrolled participants
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| ID | Title | Description |
|---|---|---|
| BG000 | MDT-2215 | 17mm MDT-2215 aortic valve bioprosthesis |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Changes in NYHA Classification From Baseline to 1 Year Post-procedure | Change in New York Heart Association (NYHA) functional classification from baseline to 1 year post-procedure will be evaluated. 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. | Posted | Count of Participants | Participants | This outcome will be identified from measurement at baseline and 1 year. |
|
Adverse events were collected from baseline through study exit, up to 5 years.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MDT-2215 | 17mm MDT-2215 aortic valve bioprosthesis | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mediastinal Disorders | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemias | Blood and lymphatic system disorders | Non-systematic Assessment | Procedure-Related |
Every effort was undertaken to minimize missing data. Unless otherwise specified in each objective, no statistical techniques were used to impute missing data for continuous or categorical outcomes. If a subject's data were missing for any reason, that subject was not included in that portion of the analysis. The number of subjects included in each analysis was reported so that the reader can assess the potential impact of missing data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessica Halverson, Clinical Research Director | Medtronic | (800) 633-8766 | rs.perigonjapantrial@medtronic.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 21, 2019 | Oct 16, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 29, 2021 | Oct 16, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D006349 | Heart Valve Diseases |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
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| This outcome will be evaluated at baseline, discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years. |
| Mean Effective Orifice Area Index (cm^2/m^2) From Baseline up to 5 Years | Effective orifice area index at baseline, discharge up to 30 days, 3-6 months, 1 year and annually thereafter through 5 years as measured by effective orifice area (cm^2) per unit body surface area (m^2). The achievement criterion for the effective orifice area index (EOAI) is defined to be ≥0.6 cm^2/m^2. Effective Orifice Area Index (EOAI) in cm^2/m^2 EOAI = EOA/BSA Where: EOA is the effective orifice area in cm^2, and BSA is the body surface area in m^2 | This outcome will be evaluated at baseline, discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years. |
| Effective Orifice Area (cm^2) From Baseline up to 5 Years | This will be measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory. | This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years. |
| Peak Pressure Gradient (mmHg) From Discharge up to 5 Years | This will be measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory. | This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years. |
| Mean Pressure Gradient (mmHg) From Discharge up to 5 Years | This will be measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory. | This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years. |
| Degree of Paravalvular Regurgitation From Discharge up to 5 Years | This will be measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory. | This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years. |
| Degree of Transvalvular Regurgitation From Discharge up to 5 Years | This will be measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory. | This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years. |
| Degree of Total Valvular Regurgitation From Discharge up to 5 Years | This will be measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory. | This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years. |
| Performance Index (L/Min) From Discharge up to 5 Years | This will be measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory. | This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years. |
| Cardiac Output (L/Min) From Discharge up to 5 Years | This will be measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory. | This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years. |
| Cardiac Index (L/Min/m^2) From Discharge up to 5 Years | This will be measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory. | This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years. |
| Safety:Valve-related Adverse Events | The early (<=30days post-procedure), late (>30days post-procedure) and 1-year participant counts of the following valve-related adverse events will be evaluated:
| This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years. |
| Quality of Life Assessment - Physical Component Summary (Physical Functioning, Role-physical, Bodily Pain, General Health, Vitality) | SF-36 Questionnaire Physical Component Summary (physical functioning, role-physical, bodily pain, general health, vitality) at baseline, 3-6 months, 1 year and annually thereafter through 5 years, where a higher score indicates a higher physical quality of life. Physical Component Summary Scale Lowest possible score: -7.28 Highest possible score: 52.71 | This outcome will be evaluated at baseline, 3-6 months, 1 year and annually thereafter up to 5 years. |
| Quality of Life Assessment - Mental Component Summary (Social Functioning, Role-emotional, Mental Health) | SF-36 Questionnaire Mental Component Summary (social functioning, role-emotional, mental health) at baseline, 3-6 months, 1 year and annually thereafter through 5 years, where a higher score indicates a higher quality of mental life. Lowest possible score: 31.63 Highest possible score: 66.69 | This outcome will be evaluated at baseline, 3-6 months, 1 year and annually thereafter up to 5 years. |
| Hyogo Prefecture |
| 650-0017 |
| Japan |
| Hyogo Prefectural Harima-Himeji General Medical Center | Hyogo Prefecture | 670-8560 | Japan |
| University Hospital, Kyoto Prefectural University of Medicine | Kyoto | 602-8566 | Japan |
| Kurashiki Central Hospital | Okayama | 710-8602 | Japan |
| National Cerebral and Cardiovascular Center | Osaka | 564-8565 | Japan |
| Saitama Medical Center, Jichi Medical University | Saitama | 330-8503 | Japan |
| Saitama Medical University International Medical Center | Saitama | 350-1298 | Japan |
| Tokushima Red Cross Hospital | Tokushima | 773-8502 | Japan |
| Sakakibara Heart Institute | Tokyo | 183-0003 | Japan |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Baseline characteristics were summarized only on those implanted. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Baseline characteristics were summarized only on those implanted. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| New York Heart Association (NYHA) Classification | Cardiac Disease with Functional Classes 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. | Baseline characteristics were summarized only on those implanted. | Count of Participants | Participants |
|
17mm MDT-2215 aortic valve bioprosthesis |
|
|
| Primary | Effective Orifice Area Index at Baseline and 1 Year Post-procedure | Effective Orifice Area Index (EOAI) at 1 year post-procedure will be evaluated. Effective Orifice Area Index (EOAI) in cm^2/m^2 EOAI = EOA/BSA Where: EOA is the effective orifice area in cm^2, and BSA is the body surface area in m^2 | Posted | Mean | Standard Deviation | cm^2/m^2 | This outcome will be measured at 1 year. |
|
|
|
| Primary | Number of Participants With Composite New York Heart Association (NYHA) Classification and Effective Orifice EOAI Endpoint Improvement From Baseline to 1 Year | Composite number of participants with NYHA change from baseline to 1 year post-procedure of 1 or greater and effective number of participants with effective EOAI 0.6cm^2/m^2 or greater at 1 year post implant will be evaluated. The objective is met if at least 60% of the subjects achieve the specified improvement in NYHA and EOAI. See Objective 1 for NYHA definition See Objective 2 for EOAI definition | Posted | Count of Participants | Participants | This outcome will be identified from measurement at baseline and 1 year. |
|
|
|
| Secondary | Assessment of NYHA Functional Classification for Participants From Baseline up to 5 Years | NYHA functional classification evaluation at baseline, discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years. Measure Description: Cardiac Disease with Functional Classes 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. | Subjects excited prior to visit. Year 2: 1 subject (death) Year 4: 1 subject (withdraw/other) Year 5: 3 subjects (withdraw/other) | Posted | Count of Participants | Participants | This outcome will be evaluated at baseline, discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years. |
|
|
|
| Secondary | Mean Effective Orifice Area Index (cm^2/m^2) From Baseline up to 5 Years | Effective orifice area index at baseline, discharge up to 30 days, 3-6 months, 1 year and annually thereafter through 5 years as measured by effective orifice area (cm^2) per unit body surface area (m^2). The achievement criterion for the effective orifice area index (EOAI) is defined to be ≥0.6 cm^2/m^2. Effective Orifice Area Index (EOAI) in cm^2/m^2 EOAI = EOA/BSA Where: EOA is the effective orifice area in cm^2, and BSA is the body surface area in m^2 | Subject data for this outcome measure is limited by the number of subjects remaining in study at each timepoint and limited to those with non-missing measurements. | Posted | Mean | Standard Deviation | cm^2/m^2 | This outcome will be evaluated at baseline, discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years. |
|
|
|
| Secondary | Effective Orifice Area (cm^2) From Baseline up to 5 Years | This will be measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory. | Subject data for this outcome measure is limited by the number of subjects remaining in study at each timepoint and limited to those with non-missing measurements. | Posted | Mean | Standard Deviation | cm^2 | This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years. |
|
|
|
| Secondary | Peak Pressure Gradient (mmHg) From Discharge up to 5 Years | This will be measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory. | Subject data for this outcome measure is limited by the number of subjects remaining in study at each timepoint and limited to those with non-missing measurements. | Posted | Mean | Standard Deviation | mmHg | This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years. |
|
|
|
| Secondary | Mean Pressure Gradient (mmHg) From Discharge up to 5 Years | This will be measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory. | Subject data for this outcome measure is limited by the number of subjects remaining in study at each timepoint and limited to those with non-missing measurements. | Posted | Mean | Standard Deviation | mmHg | This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years. |
|
|
|
| Secondary | Degree of Paravalvular Regurgitation From Discharge up to 5 Years | This will be measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory. | Subject data for this outcome measure is limited by the number of subjects remaining in study at each timepoint and limited to those with non-missing measurements. | Posted | Count of Participants | Participants | This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years. |
|
|
|
| Secondary | Degree of Transvalvular Regurgitation From Discharge up to 5 Years | This will be measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory. | Subject data for this outcome measure is limited by the number of subjects remaining in study at each timepoint and limited to those with non-missing measurements. | Posted | Count of Participants | Participants | This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years. |
|
|
|
| Secondary | Degree of Total Valvular Regurgitation From Discharge up to 5 Years | This will be measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory. | Subject data for this outcome measure is limited by the number of subjects remaining in study at each timepoint and limited to those with non-missing measurements. | Posted | Count of Participants | Participants | This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years. |
|
|
|
| Secondary | Performance Index (L/Min) From Discharge up to 5 Years | This will be measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory. | Subject data for this outcome measure is limited by the number of subjects remaining in study at each timepoint and limited to those with non-missing measurements. | Posted | Mean | Standard Deviation | L/min | This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years. |
|
|
|
| Secondary | Cardiac Output (L/Min) From Discharge up to 5 Years | This will be measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory. | Subject data for this outcome measure is limited by the number of subjects remaining in study at each timepoint and limited to those with non-missing measurements. | Posted | Mean | Standard Deviation | L/min | This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years. |
|
|
|
| Secondary | Cardiac Index (L/Min/m^2) From Discharge up to 5 Years | This will be measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory. | Subject data for this outcome measure is limited by the number of subjects remaining in study at each timepoint and limited to those with non-missing measurements. | Posted | Mean | Standard Deviation | L/min/m^2 | This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years. |
|
|
|
| Secondary | Safety:Valve-related Adverse Events | The early (<=30days post-procedure), late (>30days post-procedure) and 1-year participant counts of the following valve-related adverse events will be evaluated:
| Posted | Count of Participants | Participants | This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years. |
|
|
|
| Secondary | Quality of Life Assessment - Physical Component Summary (Physical Functioning, Role-physical, Bodily Pain, General Health, Vitality) | SF-36 Questionnaire Physical Component Summary (physical functioning, role-physical, bodily pain, general health, vitality) at baseline, 3-6 months, 1 year and annually thereafter through 5 years, where a higher score indicates a higher physical quality of life. Physical Component Summary Scale Lowest possible score: -7.28 Highest possible score: 52.71 | Subject data for this outcome measure is limited by the number of subjects remaining in study at each timepoint and limited to those with non-missing measurements. No SF-36 quality of life assessment was collected at 5 years. | Posted | Mean | Standard Deviation | score on a scale | This outcome will be evaluated at baseline, 3-6 months, 1 year and annually thereafter up to 5 years. |
|
|
|
|
| Secondary | Quality of Life Assessment - Mental Component Summary (Social Functioning, Role-emotional, Mental Health) | SF-36 Questionnaire Mental Component Summary (social functioning, role-emotional, mental health) at baseline, 3-6 months, 1 year and annually thereafter through 5 years, where a higher score indicates a higher quality of mental life. Lowest possible score: 31.63 Highest possible score: 66.69 | Subject data for this outcome measure is limited by the number of subjects remaining in study at each timepoint and limited to those with non-missing measurements. No SF-36 quality of life assessment was collected at 5 years. | Posted | Mean | Standard Deviation | score on a scale | This outcome will be evaluated at baseline, 3-6 months, 1 year and annually thereafter up to 5 years. |
|
|
|
|
| 11 |
| 2 |
| 11 |
| 10 |
| 11 |
| Pneumothorax and Pleural Effusions Nec | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
|
| Thrombocytopenias | Blood and lymphatic system disorders | Non-systematic Assessment | Procedure-Related |
|
| Supraventricular Arrhythmias | Cardiac disorders | Non-systematic Assessment | Procedure-Related |
|
| Ventricular Arrhythmias and Cardiac Arrest | Cardiac disorders | Non-systematic Assessment | Procedure-Related |
|
| Coagulation and Bleeding Analyses | Investigations | Non-systematic Assessment | Procedure-Related |
|
| Digestive Enzymes | Investigations | Non-systematic Assessment | Procedure-Related |
|
| Hepatobiliary Function Diagnostic Procedures | Investigations | Non-systematic Assessment | Procedure-Related |
|
| Protein Metabolism Disorders | Metabolism and nutrition disorders | Non-systematic Assessment | Procedure-Related |
|
| Disturbances in Initiating and Maintaining Sleep | Psychiatric disorders | Non-systematic Assessment | Procedure-Related |
|
| Conditions Associated with Abnormal Gas Exchange | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Procedure-Related |
|
| Mediastinal Disorders | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Procedure-Related |
|
| Pneumothorax and Pleural Effusions | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Procedure-Related |
|
| Vascular Hypertensive Disorders | Vascular disorders | Non-systematic Assessment | Procedure-Related |
|
| Upper Respiratory Tract Infections | Infections and infestations | Non-systematic Assessment | Procedure-Related |
|
| Supraventricular Arrhythmias | Cardiac disorders | Non-systematic Assessment | Device - Related |
|
Not provided
Not provided
| NYHA Classification III |
|
| NYHA Classification IV |
|
| NYHA Classification V |
|
| Not done |
|
| Discharge up to 30 days |
|
|
| 3-6 Months |
|
|
| 1 Year |
|
|
| 2 Year |
|
|
| 3 Year |
|
|
| 4 Year |
|
|
| 5 Year |
|
|
|
| 3-6 Month |
|
|
| 1 Year |
|
|
| 2 Year |
|
|
| 3 Year |
|
|
| 4 Year |
|
|
| 5 Year |
|
|
|
| 3-6 Month |
|
|
| 1 Year |
|
|
| 2 Year |
|
|
| 3 Year |
|
|
| 4 Year |
|
|
| 5 Year |
|
|
|
| 3-6 Month |
|
|
| 1 Year |
|
|
| 2 Year |
|
|
| 3 Year |
|
|
| 4 Year |
|
|
| 5 Year |
|
|
|
| 3-6 Month |
|
|
| 1 Year |
|
|
| 2 Year |
|
|
| 3 Year |
|
|
| 4 Year |
|
|
| 5 Year |
|
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Not Acquired |
|
| Not Evaluable |
|
| 3-6 Months |
|
|
| 1 Year |
|
|
| 2 Year |
|
|
| 3 Year |
|
|
| 4 Year |
|
|
| 5 Year |
|
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Not Acquired |
|
| Not Evaluable |
|
| Discharge up to 30 Days |
|
|
| 3-6 Months |
|
|
| 1 Year |
|
|
| 2 Year |
|
|
| 3 Year |
|
|
| 4 Year |
|
|
| 5 Year |
|
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Not Acquired |
|
| Not Evaluable |
|
| Discharge up to 30 Days |
|
|
| 3-6 Month |
|
|
| 1 Year |
|
|
| 2 Year |
|
|
| 3 Year |
|
|
| 4 Year |
|
|
| 5 Year |
|
|
|
| 3-6 Month |
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| 1 Year |
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| 2 Year |
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| 3 Year |
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| 4 Year |
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| 5 Year |
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| 3-6 Month |
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| 1 Year |
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| 2 Year |
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| 3 Year |
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| 4 Year |
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| 5 Year |
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| 3-6 Months |
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| 1 Year |
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| 2 Year |
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| 3 Year |
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| 4 Year |
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| 5 Year |
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| Title | Measurements |
|---|---|
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| Structural Valve Deterioration |
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| 1 Year |
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| 2 Year |
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| 3 Year |
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| 4 Year |
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1 Year compared to Baseline |
| Wilcoxon signed-rank test |
| 0.8984 |
| Median Difference (Final Values) |
| 3.9 |
| 2-Sided |
| Equivalence |
Each of the scales, for each follow-up time compared to baseline, the null hypothesis that the median paired difference is zero will be tested against the two-sided alternative that the median is not zero. Wilcoxon signed-rank test will be used. |
| 2 Year compared to Baseline | Wilcoxon signed-rank test | 0.8457 | Median Difference (Final Values) | -0.0 | 2-Sided | Equivalence | Each of the scales, for each follow-up time compared to baseline, the null hypothesis that the median paired difference is zero will be tested against the two-sided alternative that the median is not zero. Wilcoxon signed-rank test will be used. |
| 3 Year compared to Baseline | Wilcoxon signed-rank test | 0.1309 | Median Difference (Final Values) | -7.7 | 2-Sided | Equivalence | Each of the scales, for each follow-up time compared to baseline, the null hypothesis that the median paired difference is zero will be tested against the two-sided alternative that the median is not zero. Wilcoxon signed-rank test will be used. |
| 4 Year compared to Baseline | Wilcoxon signed-rank test | 0.5000 | Median Difference (Final Values) | -15.2 | 2-Sided | Equivalence | Each of the scales, for each follow-up time compared to baseline, the null hypothesis that the median paired difference is zero will be tested against the two-sided alternative that the median is not zero. Wilcoxon signed-rank test will be used. |
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| 1 Year |
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| 2 Year |
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| 3 Year |
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| 4 Year |
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1 Year compared to Baseline |
| Wilcoxon signed-rank test |
| 0.0674 |
| Median Difference (Final Values) |
| 6.4 |
| 2-Sided |
| Equivalence |
Each of the scales, for each follow-up time compared to baseline, the null hypothesis that the median paired difference is zero will be tested against the two-sided alternative that the median is not zero. Wilcoxon signed-rank test will be used. |
| 2 Year compared to Baseline | Wilcoxon signed-rank test | 0.0371 | Median Difference (Final Values) | 6.4 | 2-Sided | Equivalence | Each of the scales, for each follow-up time compared to baseline, the null hypothesis that the median paired difference is zero will be tested against the two-sided alternative that the median is not zero. Wilcoxon signed-rank test will be used. |
| 3 Year compared to Baseline | Wilcoxon signed-rank test | 0.6953 | Median Difference (Final Values) | 0.8 | 2-Sided | Equivalence | Each of the scales, for each follow-up time compared to baseline, the null hypothesis that the median paired difference is zero will be tested against the two-sided alternative that the median is not zero. Wilcoxon signed-rank test will be used. |
| 4 Year compared to Baseline | Wilcoxon signed-rank test | >0.9999 | Median Difference (Final Values) | 1.0 | 2-Sided | Equivalence | Each of the scales, for each follow-up time compared to baseline, the null hypothesis that the median paired difference is zero will be tested against the two-sided alternative that the median is not zero. Wilcoxon signed-rank test will be used. |