Aortic Valve Stenosis
Conditions
Brief summary
The purpose of the study is to obtain safety and effectiveness data of the Medtronic Evolut™ PRO+ TAVR System for the treatment of severe, asymptomatic aortic stenosis.
Detailed description
Single-arm, descriptive, multi-center, international All subjects will be treated with a Medtronic Evolut™ PRO+ TAVR System. Subject follow-ups will be conducted at pre and post-procedure, discharge, 30 days, 6 months, and annually through 5 years.
Interventions
DEVICEMedtronic Evolut™ PRO+ System
TAVR treatment with Medtronic Evolut™ PRO+ System
Sponsors
Medtronic Cardiovascular
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Severe aortic stenosis, defined as: Aortic valve area ≤ 1.0 cm\^2, or aortic valve area index ≤ 0.6 cm\^2/m\^2, and mean gradient ≥ 40 mmHg or Vmax ≥ 4.0 m/sec * Subject denies symptoms attributable to aortic stenosis, including but not limited to: * Dyspnea on rest or exertion * Angina * Syncope in the absence of another identifiable cause * Fatigue * Left Ventricular Ejection Fraction (LVEF) \>50% Key
Exclusion criteria
* Age \<65 years * Class I indication for cardiac surgery * Bicuspid, unicuspid, or quadricuspid aortic valve * In need of and suitable for coronary revascularization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in NT-pro B-type Natriuretic Peptide (NT-proBNP) | 6 months | Reporting of change in NT-pro B-type natriuretic peptide (NT-proBNP) from baseline |
| New-onset Atrial Fibrillation | 30 days | Rate of new-onset atrial fibrillation (excludes patients with atrial fibrillation at baseline) |
| Valve-related Dysfunction Requiring Repeat Procedure | 30 days | Rate of valve-related dysfunction requiring repeat procedure |
| Device Success (VARC-2) | Discharge (12 hours to 7 days post-procedure) | The VARC-2 definition of device success is absence of procedural mortality, correct positioning of a single prosthetic heart valve into the proper anatomical location, intended performance of the prosthetic heart valve, defined as the absence of patient-prosthesis-mismatch and mean aortic valve gradient less than 20 mmHg (or peak velocity \<3 m/sec), and absence of moderate or severe prosthetic valve regurgitation |
| Cardiovascular and Heart Failure Hospitalizations | 30 days | Rate of cardiovascular and heart failure hospitalizations |
| Heart Failure Events | 30 days | Rate of heart failure events |
| Hemodynamic Performance Metrics (Mean Aortic Gradient) by Doppler Echocardiography | Discharge (12 hours to 7 days post-procedure) | Reporting of prosthetic valve hemodynamic performance by transvalvular mean aortic gradient |
| Hemodynamic Performance Metrics (Effective Orifice Area) by Doppler Echocardiography | Discharge (12 hours to 7 days post-procedure) | Change in hemodynamic performance metrics by Doppler echocardiography measured by effective orifice area. |
| Hemodynamic Performance Metrics (Degree of Total, Para, and Transvalvular Prosthetic Regurgitation) by Doppler Echocardiography | Discharge (12 hours to 7 days post-procedure) | Reporting of prosthetic valve hemodynamic performance by degree of total, para, and transvalvular regurgitation by Doppler echocardiography |
| Hemodynamic Performance Metrics (Incidence of Moderate and Severe Patient-prosthesis Mismatch) by Doppler Echocardiography | Discharge (12 hours to 7 days post-procedure) | Reporting of prosthetic valve hemodynamic performance by incidence of moderate and severe patient-prosthesis mismatch by Doppler echocardiography |
| Change From Baseline in New York Heart Association (NYHA) Functional Classification | 30 days and 6 months | Reporting of NYHA classification change from baseline to 30 days and 6 months NYHA Classification criteria: Class I: Subjects with cardiac disease but without resulting limitations of physical activity. Class I: Subjects with cardiac disease resulting in slight limitation of physical activity. Class III: Subjects with cardiac disease resulting in marked limitation of physical activity. Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. |
| Change From Baseline in Six-minute Walk Test (6MWT) | 6 months | Reporting change from baseline in distance walked during 6MWT |
| Change From Baseline in Health-related Quality of Life (QoL) as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) | 30 days and 6 months | KCCQ quantifies physical function, symptoms, social function, self-efficiency, knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. |
| Change From Baseline in Left Ventricular Ejection Fraction (LVEF) | 6 months | Reporting of change in left ventricular ejection fraction (LVEF) from baseline by echocardiography |
| Change From Baseline in Global Longitudinal Strain (GLS) | 6 months | Reporting of change in GLS from baseline by echocardiography |
| Change From Baseline in Left Ventricular Filling Pressure (E:e') | 6 months | Reporting of change in left ventricular filling pressure (E:e') from baseline by echocardiography |
| Change From Baseline in Stroke Volume Index (SVI) | 6 months | Reporting of change in stroke volume index (SVI) from baseline by echocardiography |
| All-cause and Cardiovascular Mortality | 30 days | Rate of all-cause and cardiovascular mortality |
| All Stroke (Disabling and Non-disabling) | 30 days | Rate of disabling and non-disabling stroke |
| Myocardial Infarction (Periprocedural and Spontaneous) | 30 days | Rate of periprocedural and spontaneous myocardial infarction |
| Acute Kidney Injury | 30 days | Rate of acute kidney injury |
| Major Vascular Complications | 30 days | Rate of major vascular complications |
| Life-threatening Bleed | 30 days | Rate of life-threatening (or disabling) bleed |
| New Permanent Pacemaker Implantation (PPI) | 30 days | Rate of new permanent pacemaker implantation (excludes patients with pre-existing pacemakers at baseline) |
| New Intraventricular Conduction Delays | 30 days | Rate of new intraventricular conduction delays (excludes patients with intraventricular conduction delays at baseline) |
Other
| Measure | Time frame | Description |
|---|---|---|
| All Stroke (Disabling and Non-disabling) | Annually through 5 years | Rate of disabling and non-disabling strokes |
| Cardiovascular and Heart Failure Hospitalizations | Annually through 5 years | Rate of cardiovascular and heart failure hospitalizations |
| Heart Failure Events | Annually through 5 years | Rate of heart failure events |
| New York Heart Association (NYHA) Functional Classification | 30 days, 6 months, and annually through 5 years | Reporting NYHA functional classification by timepoint following attempted procedure |
| Change From Baseline in New York Heart Association (NYHA) Functional Classification | Annually through 5 years | Reporting of NYHA classification change from baseline to 30 days and 6 months NYHA Classification criteria: Class I: Subjects with cardiac disease but without resulting limitations of physical activity. Class I: Subjects with cardiac disease resulting in slight limitation of physical activity. Class III: Subjects with cardiac disease resulting in marked limitation of physical activity. Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. |
| Health-related Quality of Life (QoL) as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) | Annually through 5 years | KCCQ quantifies physical function, symptoms, social function, self-efficiency, knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. |
| Hemodynamic Performance Metrics (Mean Aortic Gradient) by Doppler Echocardiography | Annually through 5 years | Reporting of prosthetic valve hemodynamic performance by transvalvular mean aortic gradient |
| Hemodynamic Performance Metrics (Effective Orifice Area) by Doppler Echocardiography | Annually through 5 years | Reporting of prosthetic valve hemodynamic performance by effective orifice area (EOA) |
| Hemodynamic Performance Metrics (Degree of Total, Para, and Transvalvular Prosthetic Regurgitation) by Doppler Echocardiography | Annually through 5 years | Reporting of prosthetic valve hemodynamic performance by degree of total, para, and transvalvular prosthetic regurgitation by Doppler echocardiography |
| Hemodynamic Performance Metrics (Incidence of Moderate and Severe Patient-prosthesis Mismatch) by Doppler Echocardiography | Annually through 5 years | Reporting of prosthetic valve hemodynamic performance by incidence of moderate and severe patient-prosthesis mismatch by Doppler echocardiography |
| Prosthetic Valve Thrombosis | 30 days, 6 months, and annually through 5 years | Rate of prosthetic valve thrombosis |
| Prosthetic Valve Endocarditis | 30 days, 6 months, and annually through 5 years | Rate of prosthetic valve endocarditis |
| Bioprosthetic Valve Dysfunction (BVD) | 30 days, 6 months, and annually through 5 years | Rate of bioprosthetic valve dysfunction (BVD) |
| Bioprosthetic Valve Failure (BVF) | 30 days, 6 months, and annually through 5 years | Rate of bioprosthetic valve failure (BVF) |
| Valve-related Dysfunction Requiring Repeat Procedure | Annually through 5 years | Rate of valve-related dysfunction requiring repeat procedure |
| All-cause and Cardiovascular Mortality | Annually through 5 years | Rate of all-cause and cardiovascular mortality |
Countries
Australia, Canada, Israel, New Zealand, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TAVR Up to 75 subjects with moderate, symptomatic AS with an attempted TAVR procedure | 8 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Early study termination | 3 |
| Overall Study | Physician Decision | 2 |
| Overall Study | Screen failure | 5 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | TAVR |
|---|---|
| Age, Continuous | 76.9 years |
| BSA | 1.7 m^2 |
| NYHA Classification Class I | 5 Participants |
| NYHA Classification Class II | 0 Participants |
| NYHA Classification Class III | 0 Participants |
| NYHA Classification Class IV | 0 Participants |
| NYHA Classification Unknown/Not Reported | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment Australia | 3 participants |
| Region of Enrollment New Zealand | 2 participants |
| Region of Enrollment United States | 3 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 4 Participants |
| Society of Thoracic Surgeons (STS) Score | 2.9 Percentage |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 11 |
| other Total, other adverse events | 4 / 11 |
| serious Total, serious adverse events | 2 / 11 |
Outcome results
Primary
Acute Kidney Injury
Rate of acute kidney injury
Time frame: 30 days
Population: No subjects with an attempted TAVR procedure~No data is reported as statistical analysis plan specifies that results would be reported for:~* Attempted Implant (all subjects with an attempted procedure)~* Implanted (all subjects with an attempted procedure where the study device is implanted)
Primary
Acute Kidney Injury
Rate of acute kidney injury
Time frame: 6 months
Population: No subjects with an attempted TAVR procedure.~No data is reported as statistical analysis plan specifies that results would be reported for:~* Attempted Implant (all subjects with an attempted procedure)~* Implanted (all subjects with an attempted procedure where the study device is implanted)
Primary
All-cause and Cardiovascular Mortality
Rate of all-cause and cardiovascular mortality
Time frame: 30 days
Population: No subjects with an attempted TAVR procedure.~No data is reported as statistical analysis plan specifies that results would be reported for:~* Attempted Implant (all subjects with an attempted procedure)~* Implanted (all subjects with an attempted procedure where the study device is implanted)
Primary
All-cause and Cardiovascular Mortality
Rate of all-cause and cardiovascular mortality
Time frame: 6 months
Population: No subjects with an attempted TAVR procedure.~No data is reported as statistical analysis plan specifies that results would be reported for:~* Attempted Implant (all subjects with an attempted procedure)~* Implanted (all subjects with an attempted procedure where the study device is implanted)
Primary
All Stroke (Disabling and Non-disabling)
Rate of disabling and non-disabling stroke
Time frame: 30 days
Population: No subjects with an attempted TAVR procedure.~No data is reported as statistical analysis plan specifies that results would be reported for:~* Attempted Implant (all subjects with an attempted procedure)~* Implanted (all subjects with an attempted procedure where the study device is implanted)
Primary
All Stroke (Disabling and Non-disabling)
Rate of disabling and non-disabling stroke
Time frame: 6 months
Population: No subjects with an attempted TAVR procedure.~No data is reported as statistical analysis plan specifies that results would be reported for:~* Attempted Implant (all subjects with an attempted procedure)~* Implanted (all subjects with an attempted procedure where the study device is implanted)
Primary
Cardiovascular and Heart Failure Hospitalizations
Rate of cardiovascular and heart failure hospitalizations
Time frame: 6 months
Population: No subjects with an attempted TAVR procedure.~No data is reported as statistical analysis plan specifies that results would be reported for:~* Attempted Implant (all subjects with an attempted procedure)~* Implanted (all subjects with an attempted procedure where the study device is implanted)
Primary
Cardiovascular and Heart Failure Hospitalizations
Rate of cardiovascular and heart failure hospitalizations
Time frame: 30 days
Population: No subjects with an attempted TAVR procedure.~No data is reported as statistical analysis plan specifies that results would be reported for:~* Attempted Implant (all subjects with an attempted procedure)~* Implanted (all subjects with an attempted procedure where the study device is implanted)
Primary
Change From Baseline in Global Longitudinal Strain (GLS)
Reporting of change in GLS from baseline by echocardiography
Time frame: 6 months
Population: No subjects with an attempted TAVR procedure.~No data is reported as statistical analysis plan specifies that results would be reported for:~* Attempted Implant (all subjects with an attempted procedure)~* Implanted (all subjects with an attempted procedure where the study device is implanted)
Primary
Change From Baseline in Health-related Quality of Life (QoL) as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)
KCCQ quantifies physical function, symptoms, social function, self-efficiency, knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Time frame: 30 days and 6 months
Population: No subjects with an attempted TAVR procedure.~No data is reported as statistical analysis plan specifies that results would be reported for:~* Attempted Implant (all subjects with an attempted procedure)~* Implanted (all subjects with an attempted procedure where the study device is implanted)
Primary
Change From Baseline in Left Ventricular Ejection Fraction (LVEF)
Reporting of change in left ventricular ejection fraction (LVEF) from baseline by echocardiography
Time frame: 6 months
Population: No subjects with an attempted TAVR procedure.~No data is reported as statistical analysis plan specifies that results would be reported for:~* Attempted Implant (all subjects with an attempted procedure)~* Implanted (all subjects with an attempted procedure where the study device is implanted)
Primary
Change From Baseline in Left Ventricular Filling Pressure (E:e')
Reporting of change in left ventricular filling pressure (E:e') from baseline by echocardiography
Time frame: 6 months
Population: No subjects with an attempted TAVR procedure.~No data is reported as statistical analysis plan specifies that results would be reported for:~* Attempted Implant (all subjects with an attempted procedure)~* Implanted (all subjects with an attempted procedure where the study device is implanted)
Primary
Change From Baseline in New York Heart Association (NYHA) Functional Classification
Reporting of NYHA classification change from baseline to 30 days and 6 months NYHA Classification criteria: Class I: Subjects with cardiac disease but without resulting limitations of physical activity. Class I: Subjects with cardiac disease resulting in slight limitation of physical activity. Class III: Subjects with cardiac disease resulting in marked limitation of physical activity. Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort.
Time frame: 30 days and 6 months
Population: No subjects with an attempted TAVR procedure.~No data is reported as statistical analysis plan specifies that results would be reported for:~* Attempted Implant (all subjects with an attempted procedure)~* Implanted (all subjects with an attempted procedure where the study device is implanted)
Primary
Change From Baseline in NT-pro B-type Natriuretic Peptide (NT-proBNP)
Reporting of change in NT-pro B-type natriuretic peptide (NT-proBNP) from baseline
Time frame: 6 months
Population: No subjects with an attempted TAVR procedure.~No data is reported as statistical analysis plan specifies that results would be reported for:~* Attempted Implant (all subjects with an attempted procedure)~* Implanted (all subjects with an attempted procedure where the study device is implanted)
Primary
Change From Baseline in Six-minute Walk Test (6MWT)
Reporting change from baseline in distance walked during 6MWT
Time frame: 6 months
Population: No subjects with an attempted TAVR procedure.~No data is reported as statistical analysis plan specifies that results would be reported for:~* Attempted Implant (all subjects with an attempted procedure)~* Implanted (all subjects with an attempted procedure where the study device is implanted)
Primary
Change From Baseline in Stroke Volume Index (SVI)
Reporting of change in stroke volume index (SVI) from baseline by echocardiography
Time frame: 6 months
Population: No subjects with an attempted TAVR procedure.~No data is reported as statistical analysis plan specifies that results would be reported for:~* Attempted Implant (all subjects with an attempted procedure)~* Implanted (all subjects with an attempted procedure where the study device is implanted)
Primary
Device Success (VARC-2)
The VARC-2 definition of device success is absence of procedural mortality, correct positioning of a single prosthetic heart valve into the proper anatomical location, intended performance of the prosthetic heart valve, defined as the absence of patient-prosthesis-mismatch and mean aortic valve gradient less than 20 mmHg (or peak velocity \<3 m/sec), and absence of moderate or severe prosthetic valve regurgitation
Time frame: Discharge (12 hours to 7 days post-procedure)
Population: Can only be observed following a successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure.
Primary
Heart Failure Events
Rate of heart failure events
Time frame: 30 days
Population: No subjects with an attempted TAVR procedure.~No data is reported as statistical analysis plan specifies that results would be reported for:~* Attempted Implant (all subjects with an attempted procedure)~* Implanted (all subjects with an attempted procedure where the study device is implanted)
Primary
Heart Failure Events
Rate of heart failure events
Time frame: 6 months
Population: No subjects with an attempted TAVR procedure.~No data is reported as statistical analysis plan specifies that results would be reported for:~* Attempted Implant (all subjects with an attempted procedure)~* Implanted (all subjects with an attempted procedure where the study device is implanted)
Primary
Hemodynamic Performance Metrics (Degree of Total, Para, and Transvalvular Prosthetic Regurgitation) by Doppler Echocardiography
Reporting of prosthetic valve hemodynamic performance by degree of total, para, and transvalvular regurgitation by Doppler echocardiography
Time frame: Discharge (12 hours to 7 days post-procedure)
Population: Can only be observed following an attempted or successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure.
Primary
Hemodynamic Performance Metrics (Degree of Total, Para, and Transvalvular Prosthetic Regurgitation) by Doppler Echocardiography
Reporting of prosthetic valve hemodynamic performance by degree of total, para, and transvalvular regurgitation by Doppler echocardiography
Time frame: 30 days
Population: Can only be observed following an attempted or successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure.
Primary
Hemodynamic Performance Metrics (Degree of Total, Para, and Transvalvular Prosthetic Regurgitation) by Doppler Echocardiography
Reporting of prosthetic valve hemodynamic performance by degree of total, para, and transvalvular regurgitation by Doppler echocardiography
Time frame: 6 months
Population: Can only be observed following an attempted or successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure.
Primary
Hemodynamic Performance Metrics (Effective Orifice Area) by Doppler Echocardiography
Change in hemodynamic performance metrics by Doppler echocardiography measured by effective orifice area.
Time frame: Discharge (12 hours to 7 days post-procedure)
Population: Can only be observed following an attempted or successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure.
Primary
Hemodynamic Performance Metrics (Effective Orifice Area) by Doppler Echocardiography
Change in hemodynamic performance metrics by Doppler echocardiography measured by effective orifice area.
Time frame: 6 months
Population: Can only be observed following an attempted or successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure.
Primary
Hemodynamic Performance Metrics (Effective Orifice Area) by Doppler Echocardiography
Change in hemodynamic performance metrics by Doppler echocardiography measured by effective orifice area.
Time frame: 30 days
Population: Can only be observed following an attempted or successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure.
Primary
Hemodynamic Performance Metrics (Incidence of Moderate and Severe Patient-prosthesis Mismatch) by Doppler Echocardiography
Reporting of prosthetic valve hemodynamic performance by incidence of moderate and severe patient-prosthesis mismatch by Doppler echocardiography
Time frame: Discharge (12 hours to 7 days post-procedure)
Population: Can only be observed following an attempted or successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure.
Primary
Hemodynamic Performance Metrics (Incidence of Moderate and Severe Patient-prosthesis Mismatch) by Doppler Echocardiography
Reporting of prosthetic valve hemodynamic performance by incidence of moderate and severe patient-prosthesis mismatch by Doppler echocardiography
Time frame: 30 days
Population: Can only be observed following an attempted or successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure.
Primary
Hemodynamic Performance Metrics (Incidence of Moderate and Severe Patient-prosthesis Mismatch) by Doppler Echocardiography
Reporting of prosthetic valve hemodynamic performance by incidence of moderate and severe patient-prosthesis mismatch by Doppler echocardiography
Time frame: 6 months
Population: Can only be observed following an attempted or successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure.
Primary
Hemodynamic Performance Metrics (Mean Aortic Gradient) by Doppler Echocardiography
Reporting of prosthetic valve hemodynamic performance by transvalvular mean aortic gradient
Time frame: Discharge (12 hours to 7 days post-procedure)
Population: No subjects with an attempted TAVR procedure.~No data is reported as statistical analysis plan specifies that results would be reported for:~* Attempted Implant (all subjects with an attempted procedure)~* Implanted (all subjects with an attempted procedure where the study device is implanted)
Primary
Hemodynamic Performance Metrics (Mean Aortic Gradient) by Doppler Echocardiography
Reporting of prosthetic valve hemodynamic performance by transvalvular mean aortic gradient
Time frame: 6 months
Population: No subjects with an attempted TAVR procedure.~No data is reported as statistical analysis plan specifies that results would be reported for:~* Attempted Implant (all subjects with an attempted procedure)~* Implanted (all subjects with an attempted procedure where the study device is implanted)
Primary
Hemodynamic Performance Metrics (Mean Aortic Gradient) by Doppler Echocardiography
Reporting of prosthetic valve hemodynamic performance by transvalvular mean aortic gradient
Time frame: 30 days
Population: No subjects with an attempted TAVR procedure.~No data is reported as statistical analysis plan specifies that results would be reported for:~* Attempted Implant (all subjects with an attempted procedure)~* Implanted (all subjects with an attempted procedure where the study device is implanted)
Primary
Life-threatening Bleed
Rate of life-threatening (or disabling) bleed
Time frame: 30 days
Population: No subjects with an attempted TAVR procedure.~No data is reported as statistical analysis plan specifies that results would be reported for:~* Attempted Implant (all subjects with an attempted procedure)~* Implanted (all subjects with an attempted procedure where the study device is implanted)
Primary
Life-threatening Bleed
Rate of life-threatening (or disabling) bleed
Time frame: 6 months
Population: No subjects with an attempted TAVR procedure.~No data is reported as statistical analysis plan specifies that results would be reported for:~* Attempted Implant (all subjects with an attempted procedure)~* Implanted (all subjects with an attempted procedure where the study device is implanted)
Primary
Major Vascular Complications
Rate of major vascular complications
Time frame: 30 days
Population: No subjects with an attempted TAVR procedure.~No data is reported as statistical analysis plan specifies that results would be reported for:~* Attempted Implant (all subjects with an attempted procedure)~* Implanted (all subjects with an attempted procedure where the study device is implanted)
Primary
Major Vascular Complications
Rate of major vascular complications
Time frame: 6 months
Population: No subjects with an attempted TAVR procedure.~No data is reported as statistical analysis plan specifies that results would be reported for:~* Attempted Implant (all subjects with an attempted procedure)~* Implanted (all subjects with an attempted procedure where the study device is implanted)
Primary
Myocardial Infarction (Periprocedural and Spontaneous)
Rate of periprocedural and spontaneous myocardial infarction
Time frame: 6 months
Population: No subjects with an attempted TAVR procedure.~No data is reported as statistical analysis plan specifies that results would be reported for:~* Attempted Implant (all subjects with an attempted procedure)~* Implanted (all subjects with an attempted procedure where the study device is implanted)
Primary
Myocardial Infarction (Periprocedural and Spontaneous)
Rate of periprocedural and spontaneous myocardial infarction
Time frame: 30 days
Population: No subjects with an attempted TAVR procedure.~No data is reported as statistical analysis plan specifies that results would be reported for:~* Attempted Implant (all subjects with an attempted procedure)~* Implanted (all subjects with an attempted procedure where the study device is implanted)
Primary
New Intraventricular Conduction Delays
Rate of new intraventricular conduction delays (excludes patients with intraventricular conduction delays at baseline)
Time frame: 30 days
Population: No subjects with an attempted TAVR procedure.~No data is reported as statistical analysis plan specifies that results would be reported for:~* Attempted Implant (all subjects with an attempted procedure)~* Implanted (all subjects with an attempted procedure where the study device is implanted)
Primary
New Intraventricular Conduction Delays
Rate of new intraventricular conduction delays (excludes patients with intraventricular conduction delays at baseline)
Time frame: 6 months
Population: No subjects with an attempted TAVR procedure.~No data is reported as statistical analysis plan specifies that results would be reported for:~* Attempted Implant (all subjects with an attempted procedure)~* Implanted (all subjects with an attempted procedure where the study device is implanted)
Primary
New-onset Atrial Fibrillation
Rate of new-onset atrial fibrillation (excludes patients with atrial fibrillation at baseline)
Time frame: 6 months
Population: No subjects with an attempted TAVR procedure.~No data is reported as statistical analysis plan specifies that results would be reported for:~* Attempted Implant (all subjects with an attempted procedure)~* Implanted (all subjects with an attempted procedure where the study device is implanted)
Primary
New-onset Atrial Fibrillation
Rate of new-onset atrial fibrillation (excludes patients with atrial fibrillation at baseline)
Time frame: 30 days
Population: No subjects with an attempted TAVR procedure.~No data is reported as statistical analysis plan specifies that results would be reported for:~* Attempted Implant (all subjects with an attempted procedure)~* Implanted (all subjects with an attempted procedure where the study device is implanted)
Primary
New Permanent Pacemaker Implantation (PPI)
Rate of new permanent pacemaker implantation (excludes patients with pre-existing pacemakers at baseline)
Time frame: 6 months
Population: No subjects with an attempted TAVR procedure.~No data is reported as statistical analysis plan specifies that results would be reported for:~* Attempted Implant (all subjects with an attempted procedure)~* Implanted (all subjects with an attempted procedure where the study device is implanted)
Primary
New Permanent Pacemaker Implantation (PPI)
Rate of new permanent pacemaker implantation (excludes patients with pre-existing pacemakers at baseline)
Time frame: 30 days
Population: No subjects with an attempted TAVR procedure.~No data is reported as statistical analysis plan specifies that results would be reported for:~* Attempted Implant (all subjects with an attempted procedure)~* Implanted (all subjects with an attempted procedure where the study device is implanted)
Primary
Valve-related Dysfunction Requiring Repeat Procedure
Rate of valve-related dysfunction requiring repeat procedure
Time frame: 30 days
Population: Can only be observed following a successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure.
Primary
Valve-related Dysfunction Requiring Repeat Procedure
Rate of valve-related dysfunction requiring repeat procedure
Time frame: 6 months
Population: Can only be observed following a successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure.
Other Pre-specified
All-cause and Cardiovascular Mortality
Rate of all-cause and cardiovascular mortality
Time frame: Annually through 5 years
Population: No subjects with an attempted TAVR procedure.~No data is reported as statistical analysis plan specifies that results would be reported for:~* Attempted Implant (all subjects with an attempted procedure)~* Implanted (all subjects with an attempted procedure where the study device is implanted)
Other Pre-specified
All Stroke (Disabling and Non-disabling)
Rate of disabling and non-disabling strokes
Time frame: Annually through 5 years
Population: No subjects with an attempted TAVR procedure.~No data is reported as statistical analysis plan specifies that results would be reported for:~* Attempted Implant (all subjects with an attempted procedure)~* Implanted (all subjects with an attempted procedure where the study device is implanted)
Other Pre-specified
Bioprosthetic Valve Dysfunction (BVD)
Rate of bioprosthetic valve dysfunction (BVD)
Time frame: 30 days, 6 months, and annually through 5 years
Population: Can only be observed following a successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure.
Other Pre-specified
Bioprosthetic Valve Failure (BVF)
Rate of bioprosthetic valve failure (BVF)
Time frame: 30 days, 6 months, and annually through 5 years
Population: Can only be observed following a successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure.
Other Pre-specified
Cardiovascular and Heart Failure Hospitalizations
Rate of cardiovascular and heart failure hospitalizations
Time frame: Annually through 5 years
Population: No subjects with an attempted TAVR procedure.~No data is reported as statistical analysis plan specifies that results would be reported for:~* Attempted Implant (all subjects with an attempted procedure)~* Implanted (all subjects with an attempted procedure where the study device is implanted)
Other Pre-specified
Change From Baseline in New York Heart Association (NYHA) Functional Classification
Reporting of NYHA classification change from baseline to 30 days and 6 months NYHA Classification criteria: Class I: Subjects with cardiac disease but without resulting limitations of physical activity. Class I: Subjects with cardiac disease resulting in slight limitation of physical activity. Class III: Subjects with cardiac disease resulting in marked limitation of physical activity. Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort.
Time frame: Annually through 5 years
Population: No subjects with an attempted TAVR procedure.~No data is reported as statistical analysis plan specifies that results would be reported for:~* Attempted Implant (all subjects with an attempted procedure)~* Implanted (all subjects with an attempted procedure where the study device is implanted)
Other Pre-specified
Health-related Quality of Life (QoL) as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)
KCCQ quantifies physical function, symptoms, social function, self-efficiency, knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Time frame: Annually through 5 years
Population: No subjects with an attempted TAVR procedure.~No data is reported as statistical analysis plan specifies that results would be reported for:~* Attempted Implant (all subjects with an attempted procedure)~* Implanted (all subjects with an attempted procedure where the study device is implanted)
Other Pre-specified
Heart Failure Events
Rate of heart failure events
Time frame: Annually through 5 years
Population: No subjects with an attempted TAVR procedure.~No data is reported as statistical analysis plan specifies that results would be reported for:~* Attempted Implant (all subjects with an attempted procedure)~* Implanted (all subjects with an attempted procedure where the study device is implanted)
Other Pre-specified
Hemodynamic Performance Metrics (Degree of Total, Para, and Transvalvular Prosthetic Regurgitation) by Doppler Echocardiography
Reporting of prosthetic valve hemodynamic performance by degree of total, para, and transvalvular prosthetic regurgitation by Doppler echocardiography
Time frame: Annually through 5 years
Population: Can only be observed following an attempted or successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure.
Other Pre-specified
Hemodynamic Performance Metrics (Effective Orifice Area) by Doppler Echocardiography
Reporting of prosthetic valve hemodynamic performance by effective orifice area (EOA)
Time frame: Annually through 5 years
Population: Can only be observed following an attempted or successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure.
Other Pre-specified
Hemodynamic Performance Metrics (Incidence of Moderate and Severe Patient-prosthesis Mismatch) by Doppler Echocardiography
Reporting of prosthetic valve hemodynamic performance by incidence of moderate and severe patient-prosthesis mismatch by Doppler echocardiography
Time frame: Annually through 5 years
Population: Can only be observed following an attempted or successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure.
Other Pre-specified
Hemodynamic Performance Metrics (Mean Aortic Gradient) by Doppler Echocardiography
Reporting of prosthetic valve hemodynamic performance by transvalvular mean aortic gradient
Time frame: Annually through 5 years
Population: Can only be observed following an attempted or successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure.
Other Pre-specified
New York Heart Association (NYHA) Functional Classification
Reporting NYHA functional classification by timepoint following attempted procedure
Time frame: 30 days, 6 months, and annually through 5 years
Population: No subjects with an attempted TAVR procedure.~No data is reported as statistical analysis plan specifies that results would be reported for:~* Attempted Implant (all subjects with an attempted procedure)~* Implanted (all subjects with an attempted procedure where the study device is implanted)
Other Pre-specified
Prosthetic Valve Endocarditis
Rate of prosthetic valve endocarditis
Time frame: 30 days, 6 months, and annually through 5 years
Population: Can only be observed following a successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure.
Other Pre-specified
Prosthetic Valve Thrombosis
Rate of prosthetic valve thrombosis
Time frame: 30 days, 6 months, and annually through 5 years
Population: Can only be observed following a successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure.
Other Pre-specified
Valve-related Dysfunction Requiring Repeat Procedure
Rate of valve-related dysfunction requiring repeat procedure
Time frame: Annually through 5 years
Population: Can only be observed following a successful TAVR procedure. Cannot be reported on as there were no subjects with an attempted or successful TAVR procedure.