Aortic Valve Stenosis
Conditions
Brief summary
The study objective is to demonstrate that the safety and effectiveness of the Medtronic TAVR system as measured by rates of all-cause mortality or disabling stroke at two years is noninferior to SAVR in the treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR. The purpose of the expanded use addendum to the Medtronic TAVR in Low Risk Patients Trial protocol is to conclude the randomized phase of the trial and initiate the single-arm, non-randomized, continued access phase of the trial.
Detailed description
Multi-center, international, prospective, randomized, interventional, pre-market. Subjects will be randomized on 1:1 basis to either TAVR with the Medtronic TAVR system or to SAVR. Patients will be seen at pre and post-procedure, discharge, 30 days, 6 months, 1 year, 18 months, and annually through 10 years. The expanded use addendum is a multi-center, prospective, non-randomized continued access trial. All heart team approved subjects will be assigned to TAVR with the Medtronic TAVR system. Patients will be seen at pre and post-procedure, discharge, 30 days, and annually through 10 years. Enrollment is expected not to exceed 3660 attempted implants in the United States.
Interventions
DEVICEMedtronic Transcatheter Aortic Valve Replacement Systems
Treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR with Medtronic TAVR Systems
Treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR with a commercially approved surgical bioprothesis
Sponsors
Medtronic Cardiovascular
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Severe aortic stenosis, defined as follows: 1. For symptomatic patients: Aortic valve area ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), OR mean gradient ≥40 mmHg, OR Maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest 2. For asymptomatic patients: * Very severe aortic stenosis with an aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND maximal aortic velocity ≥5.0 m/sec , or mean gradient ≥60 mmHg by transthoracic echocardiography at rest, OR * Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND a mean gradient ≥40 mmHg or maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest, AND an exercise tolerance test that demonstrates a limited exercise capacity, abnormal BP response, or arrhythmia OR * Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND mean gradient ≥40 mmHg, or maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest, AND a left ventricular ejection fraction \<50%. 2. Documented heart team agreement of low risk for SAVR, where low risk is defined as predicted risk of mortality for SAVR \<3% at 30 days per multidisciplinary local heart team assessment. 3. The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.
Exclusion criteria
1. Any condition considered a contraindication for placement of a bioprosthetic valve (eg, subject is indicated for mechanical prosthetic valve). 2. A known hypersensitivity or contraindication to any of the following that cannot be adequately pre-medicated: 1. aspirin or heparin (HIT/HITTS) and bivalirudin 2. ticlopidine and clopidogrel 3. Nitinol (titanium or nickel) 4. contrast media 3. Blood dyscrasias as defined: leukopenia (WBC \<1000 mm3), thrombocytopenia (platelet count \<50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states. 4. Ongoing sepsis, including active endocarditis. 5. Any percutaneous coronary or peripheral interventional procedure with a bare metal stent within 30 days prior to randomization, or drug eluting stent performed within 180 days prior to randomization. 6. Multivessel coronary artery disease with a Syntax score \>22 and/or unprotected left main coronary artery. 7. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 10 weeks of Heart Team assessment. 8. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support. 9. Recent (within 2 months of Heart Team assessment) cerebrovascular accident (CVA) or transient ischemic attack (TIA). 10. Gastrointestinal (GI) bleeding that would preclude anticoagulation. 11. Subject refuses a blood transfusion. 12. Severe dementia (resulting in either inability to provide informed consent for the trial/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits). 13. Estimated life expectancy of less than 24 months due to associated non-cardiac co-morbid conditions. 14. Other medical, social, or psychological conditions that in the opinion of the investigator precludes the subject from appropriate consent or adherence to the protocol required follow-up exams. 15. Currently participating in an investigational drug or another device trial (excluding registries). 16. Evidence of an acute myocardial infarction ≤30 days before the trial procedure due to unstable coronary artery disease (WHO criteria). 17. Need for emergency surgery for any reason. 18. Subject is pregnant or breast feeding. 19. Subject is less than legal age of consent, legally incompetent, or otherwise vulnerable 20. Pre-existing prosthetic heart valve in any position. 21. Severe mitral regurgitation amenable to surgical replacement or repair. 22. Severe tricuspid regurgitation amenable to surgical replacement or repair. 23. Moderate or severe mitral stenosis amenable to surgical replacement or repair. 24. Hypertrophic obstructive cardiomyopathy with left ventricular outflow gradient. 25. Bicuspid aortic valve verified by echocardiography, MDCT, or MRI. 26. Prohibitive left ventricular outflow tract calcification. 27. Sinus of Valsalva diameter unsuitable for placement of the self-expanding bioprosthesis. 28. Aortic annulus diameter of \<18 or \>30 mm. 29. Significant aortopathy requiring ascending aortic replacement. For transfemoral or transaxillary (subclavian) access: 30. Access vessel mean diameter \<5.0 mm for Evolut 23R, 26R, or 29R mm TAV, or access vessel mean diameter \<5.5 mm for Evolut 34R mm or Evolut PRO TAV. However, for transaxillary (subclavian) access in patients with a patent LIMA, access vessel mean diameter \<5.5mm for Evolut 23R, 26R, or 29R mm TAV, or access vessel mean diameter \<6.0 mm for the Evolut 34R or Evolut PRO TAV.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety: All Cause Mortality or Disabling Stroke Rate at 24 Months, Randomized Controlled Trial Safety: All Cause Mortality or All Stroke Rate at 12 Months, Continued Access Study | Randomized Controlled Trial - 24 months Continued Access Study - 12 months | Assessment of procedural safety by: All-cause mortality: all deaths from any cause after valve intervention. This includes all cardiovascular and non-cardiovascular deaths. Disabling stroke: a modified rankin score (mRS) of 2 or more at 90 days post-stroke and an increase of at least one mRS category from an individual's pre-stroke baseline. All stroke: any stroke after valve intervention (ischemic, hemorrhagic, or undetermined stroke). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| RCT: Composite of Death, Disabling Stroke, Life-threatening Bleed, Major Vascular Complication, or AKI (II or III) at 30 Days CAS: Composite of Death, All Stroke, Life-threatening Bleed, or Major Vascular Complication at 30 Days | 30 days | Randomized Controlled Trial: Combined clinical efficacy after 30 days was defined as the composite of all-cause mortality, disabling stroke, life-threatening bleed, major vascular complication, or AKI (II or III) Continued Access Study: Combined clinical efficacy after 30 days was defined as the composite of all-cause mortality, all stroke, life-threatening bleed, or major vascular complication |
| New Pacemaker Implantation at 30 Days | 30 days | The rate of new permanent pacemaker implant at 30 days |
| Prosthetic Valve Endocarditis at 1 Year | 1 year | The rate of prosthetic valve endocarditis at 1 year |
| Prosthetic Valve Thrombosis at 1 Year | 1 year | The rate of prosthetic valve thrombosis at 1 year |
| All Stroke (Disabling and Non-disabling) at 1 Year | 1 year | The rate of all stroke (disabling and non-disabling) at 1 year |
| Life-threatening Bleeding at 1 Year | 1 year | The rate of life-threatening bleeding at 1 year |
| Valve-related Dysfunction Requiring Repeat Procedure at 1 Year | 1 year | The rate of valve-related dysfunction requiring repeat procedure at 1 year |
| Valve-related Dysfunction (Moderate or Severe Stenosis or Regurgitation) at 1 Year, Randomized Controlled Trial | 1 year | Stenosis (moderate or severe) Any of the following: 1. Peak aortic velocity \>4 m/s OR mean aortic gradient \>40 mmHg, AND EOA \<0.8 cm2 2. Peak aortic velocity \>4 m/s OR mean aortic gradient \>40 mmHg, AND EOA ≥0.8 cm2, and DVI \<0.25 3. Peak aortic velocity ≤4 m/s and mean aortic gradient ≤ 40 mmHg, AND EOA \<0.8 cm2, and DVI \<0.25 Regurgitation (moderate or severe) Any of the following: 1. Moderate or Severe Total Regurgitation 2. Moderate or Severe Paravalvular Regurgitation 3. Moderate or Severe Transvalvular Regurgitation |
| Randomized Controlled Trial - Health-related Quality of Life as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 30 Days and 1 Year Continued Access Study - Health-related Quality of Life as Assessed by KCCQ at 1 Year | Randomized Controlled Trial - 30 days and 1 year Continued Access Study - 1 year | Quality of life summary scores and change from baseline using the following measures: KCCQ: Quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. |
| Repeat Hospitalization for Aortic Valve Disease at 1 Year, Randomized Controlled Trial | 1 year | The rate of repeat hospitalization for aortic valve disease at 1 year |
Countries
Australia, Canada, France, Japan, Netherlands, New Zealand, United States
Contacts
PRINCIPAL_INVESTIGATORMichael Reardon, MD
The Methodist Hospital Research Institute
PRINCIPAL_INVESTIGATORJohn K. Forrest, MD
Yale New Haven Hospital
Participant flow
Pre-assignment details
Randomized Controlled Trial - As Treated Continued Access Study - Attempted Implant
Participants by arm
| Arm | Count |
|---|---|
| Randomized Controlled Trial - Medtronic TAVR Systems Treatment with Medtronic CoreValve, Evolut R, and Evolut PRO systems in the Randomized Controlled Trial | 730 |
| Randomized Controlled Trial - SAVR Surgical Aortic Valve Replacement (SAVR) in the Randomized Controlled Trial | 684 |
| Continued Access Study - Medtronic TAVR Systems Treatment with Medtronic Evolut R and Evolut PRO systems in the Continued Access Study | 745 |
| Total | 2,159 |
Baseline characteristics
| Characteristic | Randomized Controlled Trial - SAVR | Total | Randomized Controlled Trial - Medtronic TAVR Systems | Continued Access Study - Medtronic TAVR Systems |
|---|---|---|---|---|
| Age, Continuous | 73.7 Years STANDARD_DEVIATION 5.9 | 73.9 Years STANDARD_DEVIATION 5.9 | 74.1 Years STANDARD_DEVIATION 5.8 | 74.9 Years STANDARD_DEVIATION 5.9 |
| Aortic valve area (AVA) | 0.8 cm2 STANDARD_DEVIATION 0.2 | 0.8 cm2 STANDARD_DEVIATION 0.2 | 0.8 cm2 STANDARD_DEVIATION 0.2 | 0.8 cm2 STANDARD_DEVIATION 0.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | NA Participants | NA Participants | NA Participants | 25 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | NA Participants | NA Participants | NA Participants | 705 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | NA Participants | NA Participants | NA Participants | 15 Participants |
| Left Ventricular Ejection Fraction (LVEF) | 61.9 Percentage of blood ejected STANDARD_DEVIATION 7.7 | 61.8 Percentage of blood ejected STANDARD_DEVIATION 7.8 | 61.7 Percentage of blood ejected STANDARD_DEVIATION 7.9 | 61.8 Percentage of blood ejected STANDARD_DEVIATION 8 |
| Max aortic valve velocity | 4.4 m/sec STANDARD_DEVIATION 0.5 | 4.4 m/sec STANDARD_DEVIATION 0.5 | 4.4 m/sec STANDARD_DEVIATION 0.5 | 4.3 m/sec STANDARD_DEVIATION 0.5 |
| Mean aortic gradient | 46.5 mmHG STANDARD_DEVIATION 12.2 | 46.7 mmHG STANDARD_DEVIATION 12.2 | 46.9 mmHG STANDARD_DEVIATION 12.2 | 45.5 mmHG STANDARD_DEVIATION 12.5 |
| Modified Rankin Score (mRS), Randomized Controlled Trial mRS 0 | 85.0 Percent of participants | 84.4 Percent of participants | 83.8 Percent of participants | NA Percent of participants |
| Modified Rankin Score (mRS), Randomized Controlled Trial mRS1 | 8.1 Percent of participants | 8.9 Percent of participants | 9.6 Percent of participants | NA Percent of participants |
| Modified Rankin Score (mRS), Randomized Controlled Trial mRS 2 | 6.2 Percent of participants | 5.9 Percent of participants | 5.6 Percent of participants | NA Percent of participants |
| Modified Rankin Score (mRS), Randomized Controlled Trial mRS 3 | 0.7 Percent of participants | 0.9 Percent of participants | 1.0 Percent of participants | NA Percent of participants |
| Modified Rankin Score (mRS), Randomized Controlled Trial mRS 4 | 0.0 Percent of participants | 0.0 Percent of participants | 0.0 Percent of participants | NA Percent of participants |
| Modified Rankin Score (mRS), Randomized Controlled Trial mRS 5 | 0.0 Percent of participants | 0.0 Percent of participants | 0.0 Percent of participants | NA Percent of participants |
| Modified Rankin Score (mRS), Randomized Controlled Trial mRS 6 | 0.0 Percent of participants | 0.0 Percent of participants | 0.0 Percent of participants | NA Percent of participants |
| New York Heart Association Classification NYHA I | 9.2 Percent of participants | 9.8 Percent of participants | 10.4 Percent of participants | 7.2 Percent of participants |
| New York Heart Association Classification NYHA II | 62.6 Percent of participants | 63.6 Percent of participants | 64.7 Percent of participants | 64.5 Percent of participants |
| New York Heart Association Classification NYHA III | 27.8 Percent of participants | 26.2 Percent of participants | 24.8 Percent of participants | 27.7 Percent of participants |
| New York Heart Association Classification NYHA IV | 0.4 Percent of participants | 0.3 Percent of participants | 0.1 Percent of participants | 0.5 Percent of participants |
| Race (NIH/OMB) American Indian or Alaska Native | NA Participants | NA Participants | NA Participants | 3 Participants |
| Race (NIH/OMB) Asian | NA Participants | NA Participants | NA Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | NA Participants | NA Participants | NA Participants | 15 Participants |
| Race (NIH/OMB) More than one race | NA Participants | NA Participants | NA Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | NA Participants | NA Participants | NA Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | NA Participants | NA Participants | NA Participants | 15 Participants |
| Race (NIH/OMB) White | NA Participants | NA Participants | NA Participants | 707 Participants |
| Sex: Female, Male Female | 233 Participants | 745 Participants | 266 Participants | 246 Participants |
| Sex: Female, Male Male | 451 Participants | 1414 Participants | 464 Participants | 499 Participants |
| Society of Thoracic Surgeons (STS) score | 1.9 Scores on a scale STANDARD_DEVIATION 0.7 | 1.9 Scores on a scale STANDARD_DEVIATION 0.7 | 2.0 Scores on a scale STANDARD_DEVIATION 0.7 | 1.6 Scores on a scale STANDARD_DEVIATION 0.6 |
| STS factors STS Factors Atrial Fibrillation/ Atrial Flutter | 14.4 Percent of participants | 14.8 Percent of participants | 15.3 Percent of participants | 15.2 Percent of participants |
| STS factors STS Factors Cerebrovascular Disease | 12.0 Percent of participants | 11.0 Percent of participants | 10.1 Percent of participants | 2.0 Percent of participants |
| STS factors STS Factors Chronic Lung Disease (COPD) | 18.0 Percent of participants | 16.5 Percent of participants | 15.1 Percent of participants | 20.3 Percent of participants |
| STS factors STS Factors Diabetes | 30.7 Percent of participants | 31 Percent of participants | 31.4 Percent of participants | 30.4 Percent of participants |
| STS factors STS Factors Dialysis | 0.1 Percent of participants | 0.1 Percent of participants | 0.0 Percent of participants | NA Percent of participants |
| STS factors STS Factors Endocarditis | 0.0 Percent of participants | 0.0 Percent of participants | 0.0 Percent of participants | 0.0 Percent of participants |
| STS factors STS Factors Hypertension | 82.4 Percent of participants | 83.6 Percent of participants | 84.8 Percent of participants | 85.0 Percent of participants |
| STS factors STS Factors Immunosuppressive Therapy | 1.0 Percent of participants | 1.6 Percent of participants | 2.1 Percent of participants | 1.1 Percent of participants |
| STS factors STS Factors Peripheral Arterial Disease | 8.2 Percent of participants | 7.8 Percent of participants | 7.5 Percent of participants | 8.7 Percent of participants |
| STS factors STS Factors Previous CABG | 2.0 Percent of participants | 2.3 Percent of participants | 2.5 Percent of participants | 2.6 Percent of participants |
| STS factors STS Factors Previous MI | 4.8 Percent of participants | 5.7 Percent of participants | 6.6 Percent of participants | 8.1 Percent of participants |
| STS factors STS Factors Previous PCI | 12.9 Percent of participants | 13.5 Percent of participants | 14.1 Percent of participants | 18.3 Percent of participants |
| STS factors STS Factors Previous Valve Surgery | 0.0 Percent of participants | 0.0 Percent of participants | 0.0 Percent of participants | 0.0 Percent of participants |
| STS factors STS Factors Serum Creatinine >2 mg/dl | 0.1 Percent of participants | 0.3 Percent of participants | 0.4 Percent of participants | 0.4 Percent of participants |
| Subject characteristic - body surface area | 2.0 m^2 STANDARD_DEVIATION 0.2 | 2.0 m^2 STANDARD_DEVIATION 0.2 | 2.0 m^2 STANDARD_DEVIATION 0.2 | 2.0 m^2 STANDARD_DEVIATION 0.2 |
| Subject characteristic - subject age | 73.7 Years STANDARD_DEVIATION 5.9 | 73.9 Years STANDARD_DEVIATION 5.9 | 74.1 Years STANDARD_DEVIATION 5.8 | 74.9 Years STANDARD_DEVIATION 5.9 |
| Subject characteristic - SYNTAX Score I, Randomized Controlled Trial | 2.1 Scores on a scale STANDARD_DEVIATION 3.9 | 2.0 Scores on a scale STANDARD_DEVIATION 3.8 | 1.9 Scores on a scale STANDARD_DEVIATION 3.7 | NA Scores on a scale |
| Subject heart conduction disturbances | 3.8 Percent of participants | 3.5 Percent of participants | 3.3 Percent of participants | 4.2 Percent of participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 25 / 730 | 29 / 684 | 19 / 745 |
| other Total, other adverse events | 474 / 730 | 571 / 684 | 0 / 745 |
| serious Total, serious adverse events | 459 / 730 | 495 / 684 | 429 / 745 |
Outcome results
Primary
Safety: All Cause Mortality or Disabling Stroke Rate at 24 Months, Randomized Controlled Trial Safety: All Cause Mortality or All Stroke Rate at 12 Months, Continued Access Study
Assessment of procedural safety by: All-cause mortality: all deaths from any cause after valve intervention. This includes all cardiovascular and non-cardiovascular deaths. Disabling stroke: a modified rankin score (mRS) of 2 or more at 90 days post-stroke and an increase of at least one mRS category from an individual's pre-stroke baseline. All stroke: any stroke after valve intervention (ischemic, hemorrhagic, or undetermined stroke).
Time frame: Randomized Controlled Trial - 24 months Continued Access Study - 12 months
Population: Randomized Controlled Trial - As treated set Continued Access Study - Attempted implant set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Randomized Controlled Trial - Medtronic TAVR Systems | Safety: All Cause Mortality or Disabling Stroke Rate at 24 Months, Randomized Controlled Trial Safety: All Cause Mortality or All Stroke Rate at 12 Months, Continued Access Study | 4.3 Percent of participants (K-M rate) |
| Randomized Controlled Trial - SAVR | Safety: All Cause Mortality or Disabling Stroke Rate at 24 Months, Randomized Controlled Trial Safety: All Cause Mortality or All Stroke Rate at 12 Months, Continued Access Study | 6.3 Percent of participants (K-M rate) |
| Continued Access Study - Medtronic TAVR Systems | Safety: All Cause Mortality or Disabling Stroke Rate at 24 Months, Randomized Controlled Trial Safety: All Cause Mortality or All Stroke Rate at 12 Months, Continued Access Study | 5.7 Percent of participants (K-M rate) |
Comparison: Primary Hypothesis: TAVR with the Medtronic TAVR system is non-inferior to SAVR for all-cause mortality or disabling stroke rate during a fixed follow-up of 24 months for the Randomized Controlled TrialBayesian
Secondary
All Stroke (Disabling and Non-disabling) at 1 Year
The rate of all stroke (disabling and non-disabling) at 1 year
Time frame: 1 year
Population: Randomized Controlled Trial - As treated set Continued Access Study - Attempted implant set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Randomized Controlled Trial - Medtronic TAVR Systems | All Stroke (Disabling and Non-disabling) at 1 Year | 4.3 Percent of participants (K-M rate) |
| Randomized Controlled Trial - SAVR | All Stroke (Disabling and Non-disabling) at 1 Year | 4.3 Percent of participants (K-M rate) |
| Continued Access Study - Medtronic TAVR Systems | All Stroke (Disabling and Non-disabling) at 1 Year | 3.6 Percent of participants (K-M rate) |
Secondary
Life-threatening Bleeding at 1 Year
The rate of life-threatening bleeding at 1 year
Time frame: 1 year
Population: Randomized Controlled Trial - As treated set Continued Access Study - Attempted implant set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Randomized Controlled Trial - Medtronic TAVR Systems | Life-threatening Bleeding at 1 Year | 3.6 Percent of participants (K-M rate) |
| Randomized Controlled Trial - SAVR | Life-threatening Bleeding at 1 Year | 8.7 Percent of participants (K-M rate) |
| Continued Access Study - Medtronic TAVR Systems | Life-threatening Bleeding at 1 Year | 3.8 Percent of participants (K-M rate) |
Secondary
New Pacemaker Implantation at 30 Days
The rate of new permanent pacemaker implant at 30 days
Time frame: 30 days
Population: Randomized Controlled Trial - As treated set Continued Access Study - Attempted implant set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Randomized Controlled Trial - Medtronic TAVR Systems | New Pacemaker Implantation at 30 Days | 17.7 Percent of participants (K-M rate) |
| Randomized Controlled Trial - SAVR | New Pacemaker Implantation at 30 Days | 6.3 Percent of participants (K-M rate) |
| Continued Access Study - Medtronic TAVR Systems | New Pacemaker Implantation at 30 Days | 15.0 Percent of participants (K-M rate) |
Secondary
Prosthetic Valve Endocarditis at 1 Year
The rate of prosthetic valve endocarditis at 1 year
Time frame: 1 year
Population: Randomized Controlled Trial - As treated set Continued Access Study - Attempted implant set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Randomized Controlled Trial - Medtronic TAVR Systems | Prosthetic Valve Endocarditis at 1 Year | 0.1 Percent of participants (K-M rate) |
| Randomized Controlled Trial - SAVR | Prosthetic Valve Endocarditis at 1 Year | 0.5 Percent of participants (K-M rate) |
| Continued Access Study - Medtronic TAVR Systems | Prosthetic Valve Endocarditis at 1 Year | 0.4 Percent of participants (K-M rate) |
Secondary
Prosthetic Valve Thrombosis at 1 Year
The rate of prosthetic valve thrombosis at 1 year
Time frame: 1 year
Population: Randomized Controlled Trial - As treated set Continued Access Study - Attempted implant set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Randomized Controlled Trial - Medtronic TAVR Systems | Prosthetic Valve Thrombosis at 1 Year | 0.3 Percent of participants (K-M rate) |
| Randomized Controlled Trial - SAVR | Prosthetic Valve Thrombosis at 1 Year | 0.2 Percent of participants (K-M rate) |
| Continued Access Study - Medtronic TAVR Systems | Prosthetic Valve Thrombosis at 1 Year | 0.0 Percent of participants (K-M rate) |
Secondary
Randomized Controlled Trial - Health-related Quality of Life as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 30 Days and 1 Year Continued Access Study - Health-related Quality of Life as Assessed by KCCQ at 1 Year
Quality of life summary scores and change from baseline using the following measures: KCCQ: Quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Time frame: Randomized Controlled Trial - 30 days and 1 year Continued Access Study - 1 year
Population: Randomized Controlled Trial - As treated set Continued Access Study - Attempted implant set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Randomized Controlled Trial - Medtronic TAVR Systems | Randomized Controlled Trial - Health-related Quality of Life as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 30 Days and 1 Year Continued Access Study - Health-related Quality of Life as Assessed by KCCQ at 1 Year | 1 year change from baseline - Clinical | 15.3 Score on a scale | Standard Deviation 18.9 |
| Randomized Controlled Trial - Medtronic TAVR Systems | Randomized Controlled Trial - Health-related Quality of Life as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 30 Days and 1 Year Continued Access Study - Health-related Quality of Life as Assessed by KCCQ at 1 Year | 1 year KCCQ - Overall | 90.6 Score on a scale | Standard Deviation 12.7 |
| Randomized Controlled Trial - Medtronic TAVR Systems | Randomized Controlled Trial - Health-related Quality of Life as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 30 Days and 1 Year Continued Access Study - Health-related Quality of Life as Assessed by KCCQ at 1 Year | 30 day change from baseline - Overall | 20.0 Score on a scale | Standard Deviation 21.1 |
| Randomized Controlled Trial - Medtronic TAVR Systems | Randomized Controlled Trial - Health-related Quality of Life as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 30 Days and 1 Year Continued Access Study - Health-related Quality of Life as Assessed by KCCQ at 1 Year | 30 day KCCQ - Overall | 88.6 Score on a scale | Standard Deviation 14.2 |
| Randomized Controlled Trial - Medtronic TAVR Systems | Randomized Controlled Trial - Health-related Quality of Life as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 30 Days and 1 Year Continued Access Study - Health-related Quality of Life as Assessed by KCCQ at 1 Year | 30 day change from baseline - Clinical | 15.4 Score on a scale | Standard Deviation 19.6 |
| Randomized Controlled Trial - Medtronic TAVR Systems | Randomized Controlled Trial - Health-related Quality of Life as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 30 Days and 1 Year Continued Access Study - Health-related Quality of Life as Assessed by KCCQ at 1 Year | 1 year KCCQ - Clinical | 89.9 Score on a scale | Standard Deviation 13.4 |
| Randomized Controlled Trial - Medtronic TAVR Systems | Randomized Controlled Trial - Health-related Quality of Life as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 30 Days and 1 Year Continued Access Study - Health-related Quality of Life as Assessed by KCCQ at 1 Year | 1 year change from baseline - Overall | 21.6 Score on a scale | Standard Deviation 20.6 |
| Randomized Controlled Trial - Medtronic TAVR Systems | Randomized Controlled Trial - Health-related Quality of Life as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 30 Days and 1 Year Continued Access Study - Health-related Quality of Life as Assessed by KCCQ at 1 Year | 30 day KCCQ - Clinical | 89.7 Score on a scale | Standard Deviation 13.4 |
| Randomized Controlled Trial - SAVR | Randomized Controlled Trial - Health-related Quality of Life as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 30 Days and 1 Year Continued Access Study - Health-related Quality of Life as Assessed by KCCQ at 1 Year | 30 day KCCQ - Overall | 78.7 Score on a scale | Standard Deviation 18.8 |
| Randomized Controlled Trial - SAVR | Randomized Controlled Trial - Health-related Quality of Life as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 30 Days and 1 Year Continued Access Study - Health-related Quality of Life as Assessed by KCCQ at 1 Year | 1 year change from baseline - Overall | 20.7 Score on a scale | Standard Deviation 20.3 |
| Randomized Controlled Trial - SAVR | Randomized Controlled Trial - Health-related Quality of Life as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 30 Days and 1 Year Continued Access Study - Health-related Quality of Life as Assessed by KCCQ at 1 Year | 1 year KCCQ - Clinical | 90.2 Score on a scale | Standard Deviation 12.8 |
| Randomized Controlled Trial - SAVR | Randomized Controlled Trial - Health-related Quality of Life as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 30 Days and 1 Year Continued Access Study - Health-related Quality of Life as Assessed by KCCQ at 1 Year | 1 year change from baseline - Clinical | 14.8 Score on a scale | Standard Deviation 18.9 |
| Randomized Controlled Trial - SAVR | Randomized Controlled Trial - Health-related Quality of Life as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 30 Days and 1 Year Continued Access Study - Health-related Quality of Life as Assessed by KCCQ at 1 Year | 1 year KCCQ - Overall | 90.5 Score on a scale | Standard Deviation 12.4 |
| Randomized Controlled Trial - SAVR | Randomized Controlled Trial - Health-related Quality of Life as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 30 Days and 1 Year Continued Access Study - Health-related Quality of Life as Assessed by KCCQ at 1 Year | 30 day change from baseline - Overall | 9.2 Score on a scale | Standard Deviation 22.3 |
| Randomized Controlled Trial - SAVR | Randomized Controlled Trial - Health-related Quality of Life as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 30 Days and 1 Year Continued Access Study - Health-related Quality of Life as Assessed by KCCQ at 1 Year | 30 day KCCQ - Clinical | 82.6 Score on a scale | Standard Deviation 16.9 |
| Randomized Controlled Trial - SAVR | Randomized Controlled Trial - Health-related Quality of Life as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 30 Days and 1 Year Continued Access Study - Health-related Quality of Life as Assessed by KCCQ at 1 Year | 30 day change from baseline - Clinical | 7.5 Score on a scale | Standard Deviation 20.5 |
| Continued Access Study - Medtronic TAVR Systems | Randomized Controlled Trial - Health-related Quality of Life as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 30 Days and 1 Year Continued Access Study - Health-related Quality of Life as Assessed by KCCQ at 1 Year | 30 day change from baseline - Overall | NA Score on a scale | — |
| Continued Access Study - Medtronic TAVR Systems | Randomized Controlled Trial - Health-related Quality of Life as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 30 Days and 1 Year Continued Access Study - Health-related Quality of Life as Assessed by KCCQ at 1 Year | 1 year KCCQ - Clinical | NA Score on a scale | — |
| Continued Access Study - Medtronic TAVR Systems | Randomized Controlled Trial - Health-related Quality of Life as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 30 Days and 1 Year Continued Access Study - Health-related Quality of Life as Assessed by KCCQ at 1 Year | 30 day change from baseline - Clinical | NA Score on a scale | — |
| Continued Access Study - Medtronic TAVR Systems | Randomized Controlled Trial - Health-related Quality of Life as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 30 Days and 1 Year Continued Access Study - Health-related Quality of Life as Assessed by KCCQ at 1 Year | 30 day KCCQ - Clinical | NA Score on a scale | — |
| Continued Access Study - Medtronic TAVR Systems | Randomized Controlled Trial - Health-related Quality of Life as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 30 Days and 1 Year Continued Access Study - Health-related Quality of Life as Assessed by KCCQ at 1 Year | 1 year change from baseline - Overall | 24.7 Score on a scale | Standard Deviation 22.8 |
| Continued Access Study - Medtronic TAVR Systems | Randomized Controlled Trial - Health-related Quality of Life as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 30 Days and 1 Year Continued Access Study - Health-related Quality of Life as Assessed by KCCQ at 1 Year | 30 day KCCQ - Overall | NA Score on a scale | — |
| Continued Access Study - Medtronic TAVR Systems | Randomized Controlled Trial - Health-related Quality of Life as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 30 Days and 1 Year Continued Access Study - Health-related Quality of Life as Assessed by KCCQ at 1 Year | 1 year change from baseline - Clinical | NA Score on a scale | — |
| Continued Access Study - Medtronic TAVR Systems | Randomized Controlled Trial - Health-related Quality of Life as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 30 Days and 1 Year Continued Access Study - Health-related Quality of Life as Assessed by KCCQ at 1 Year | 1 year KCCQ - Overall | 91.1 Score on a scale | Standard Deviation 13.8 |
Secondary
RCT: Composite of Death, Disabling Stroke, Life-threatening Bleed, Major Vascular Complication, or AKI (II or III) at 30 Days CAS: Composite of Death, All Stroke, Life-threatening Bleed, or Major Vascular Complication at 30 Days
Randomized Controlled Trial: Combined clinical efficacy after 30 days was defined as the composite of all-cause mortality, disabling stroke, life-threatening bleed, major vascular complication, or AKI (II or III) Continued Access Study: Combined clinical efficacy after 30 days was defined as the composite of all-cause mortality, all stroke, life-threatening bleed, or major vascular complication
Time frame: 30 days
Population: As treated set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Randomized Controlled Trial - Medtronic TAVR Systems | RCT: Composite of Death, Disabling Stroke, Life-threatening Bleed, Major Vascular Complication, or AKI (II or III) at 30 Days CAS: Composite of Death, All Stroke, Life-threatening Bleed, or Major Vascular Complication at 30 Days | Death | 0.4 Percent of participants (K-M rate) |
| Randomized Controlled Trial - Medtronic TAVR Systems | RCT: Composite of Death, Disabling Stroke, Life-threatening Bleed, Major Vascular Complication, or AKI (II or III) at 30 Days CAS: Composite of Death, All Stroke, Life-threatening Bleed, or Major Vascular Complication at 30 Days | Major vascular complication | 3.7 Percent of participants (K-M rate) |
| Randomized Controlled Trial - Medtronic TAVR Systems | RCT: Composite of Death, Disabling Stroke, Life-threatening Bleed, Major Vascular Complication, or AKI (II or III) at 30 Days CAS: Composite of Death, All Stroke, Life-threatening Bleed, or Major Vascular Complication at 30 Days | Life-threatening or disabling bleed | 2.5 Percent of participants (K-M rate) |
| Randomized Controlled Trial - Medtronic TAVR Systems | RCT: Composite of Death, Disabling Stroke, Life-threatening Bleed, Major Vascular Complication, or AKI (II or III) at 30 Days CAS: Composite of Death, All Stroke, Life-threatening Bleed, or Major Vascular Complication at 30 Days | Composite event | 5.3 Percent of participants (K-M rate) |
| Randomized Controlled Trial - Medtronic TAVR Systems | RCT: Composite of Death, Disabling Stroke, Life-threatening Bleed, Major Vascular Complication, or AKI (II or III) at 30 Days CAS: Composite of Death, All Stroke, Life-threatening Bleed, or Major Vascular Complication at 30 Days | All Stroke | NA Percent of participants (K-M rate) |
| Randomized Controlled Trial - Medtronic TAVR Systems | RCT: Composite of Death, Disabling Stroke, Life-threatening Bleed, Major Vascular Complication, or AKI (II or III) at 30 Days CAS: Composite of Death, All Stroke, Life-threatening Bleed, or Major Vascular Complication at 30 Days | AKI (II or III) | 0.8 Percent of participants (K-M rate) |
| Randomized Controlled Trial - Medtronic TAVR Systems | RCT: Composite of Death, Disabling Stroke, Life-threatening Bleed, Major Vascular Complication, or AKI (II or III) at 30 Days CAS: Composite of Death, All Stroke, Life-threatening Bleed, or Major Vascular Complication at 30 Days | Disabling stroke | 0.4 Percent of participants (K-M rate) |
| Randomized Controlled Trial - SAVR | RCT: Composite of Death, Disabling Stroke, Life-threatening Bleed, Major Vascular Complication, or AKI (II or III) at 30 Days CAS: Composite of Death, All Stroke, Life-threatening Bleed, or Major Vascular Complication at 30 Days | Life-threatening or disabling bleed | 7.5 Percent of participants (K-M rate) |
| Randomized Controlled Trial - SAVR | RCT: Composite of Death, Disabling Stroke, Life-threatening Bleed, Major Vascular Complication, or AKI (II or III) at 30 Days CAS: Composite of Death, All Stroke, Life-threatening Bleed, or Major Vascular Complication at 30 Days | Composite event | 10.8 Percent of participants (K-M rate) |
| Randomized Controlled Trial - SAVR | RCT: Composite of Death, Disabling Stroke, Life-threatening Bleed, Major Vascular Complication, or AKI (II or III) at 30 Days CAS: Composite of Death, All Stroke, Life-threatening Bleed, or Major Vascular Complication at 30 Days | Death | 1.2 Percent of participants (K-M rate) |
| Randomized Controlled Trial - SAVR | RCT: Composite of Death, Disabling Stroke, Life-threatening Bleed, Major Vascular Complication, or AKI (II or III) at 30 Days CAS: Composite of Death, All Stroke, Life-threatening Bleed, or Major Vascular Complication at 30 Days | Disabling stroke | 1.6 Percent of participants (K-M rate) |
| Randomized Controlled Trial - SAVR | RCT: Composite of Death, Disabling Stroke, Life-threatening Bleed, Major Vascular Complication, or AKI (II or III) at 30 Days CAS: Composite of Death, All Stroke, Life-threatening Bleed, or Major Vascular Complication at 30 Days | Major vascular complication | 3.1 Percent of participants (K-M rate) |
| Randomized Controlled Trial - SAVR | RCT: Composite of Death, Disabling Stroke, Life-threatening Bleed, Major Vascular Complication, or AKI (II or III) at 30 Days CAS: Composite of Death, All Stroke, Life-threatening Bleed, or Major Vascular Complication at 30 Days | AKI (II or III) | 2.8 Percent of participants (K-M rate) |
| Randomized Controlled Trial - SAVR | RCT: Composite of Death, Disabling Stroke, Life-threatening Bleed, Major Vascular Complication, or AKI (II or III) at 30 Days CAS: Composite of Death, All Stroke, Life-threatening Bleed, or Major Vascular Complication at 30 Days | All Stroke | NA Percent of participants (K-M rate) |
| Continued Access Study - Medtronic TAVR Systems | RCT: Composite of Death, Disabling Stroke, Life-threatening Bleed, Major Vascular Complication, or AKI (II or III) at 30 Days CAS: Composite of Death, All Stroke, Life-threatening Bleed, or Major Vascular Complication at 30 Days | Major vascular complication | 0.4 Percent of participants (K-M rate) |
| Continued Access Study - Medtronic TAVR Systems | RCT: Composite of Death, Disabling Stroke, Life-threatening Bleed, Major Vascular Complication, or AKI (II or III) at 30 Days CAS: Composite of Death, All Stroke, Life-threatening Bleed, or Major Vascular Complication at 30 Days | Death | 0.7 Percent of participants (K-M rate) |
| Continued Access Study - Medtronic TAVR Systems | RCT: Composite of Death, Disabling Stroke, Life-threatening Bleed, Major Vascular Complication, or AKI (II or III) at 30 Days CAS: Composite of Death, All Stroke, Life-threatening Bleed, or Major Vascular Complication at 30 Days | All Stroke | 2.7 Percent of participants (K-M rate) |
| Continued Access Study - Medtronic TAVR Systems | RCT: Composite of Death, Disabling Stroke, Life-threatening Bleed, Major Vascular Complication, or AKI (II or III) at 30 Days CAS: Composite of Death, All Stroke, Life-threatening Bleed, or Major Vascular Complication at 30 Days | AKI (II or III) | NA Percent of participants (K-M rate) |
| Continued Access Study - Medtronic TAVR Systems | RCT: Composite of Death, Disabling Stroke, Life-threatening Bleed, Major Vascular Complication, or AKI (II or III) at 30 Days CAS: Composite of Death, All Stroke, Life-threatening Bleed, or Major Vascular Complication at 30 Days | Life-threatening or disabling bleed | 3.4 Percent of participants (K-M rate) |
| Continued Access Study - Medtronic TAVR Systems | RCT: Composite of Death, Disabling Stroke, Life-threatening Bleed, Major Vascular Complication, or AKI (II or III) at 30 Days CAS: Composite of Death, All Stroke, Life-threatening Bleed, or Major Vascular Complication at 30 Days | Disabling stroke | NA Percent of participants (K-M rate) |
| Continued Access Study - Medtronic TAVR Systems | RCT: Composite of Death, Disabling Stroke, Life-threatening Bleed, Major Vascular Complication, or AKI (II or III) at 30 Days CAS: Composite of Death, All Stroke, Life-threatening Bleed, or Major Vascular Complication at 30 Days | Composite event | 6.6 Percent of participants (K-M rate) |
Secondary
Repeat Hospitalization for Aortic Valve Disease at 1 Year, Randomized Controlled Trial
The rate of repeat hospitalization for aortic valve disease at 1 year
Time frame: 1 year
Population: As treated set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Randomized Controlled Trial - Medtronic TAVR Systems | Repeat Hospitalization for Aortic Valve Disease at 1 Year, Randomized Controlled Trial | 3.5 Percent of participants (K-M rate) |
| Randomized Controlled Trial - SAVR | Repeat Hospitalization for Aortic Valve Disease at 1 Year, Randomized Controlled Trial | 5.8 Percent of participants (K-M rate) |
Secondary
Valve-related Dysfunction (Moderate or Severe Stenosis or Regurgitation) at 1 Year, Randomized Controlled Trial
Stenosis (moderate or severe) Any of the following: 1. Peak aortic velocity \>4 m/s OR mean aortic gradient \>40 mmHg, AND EOA \<0.8 cm2 2. Peak aortic velocity \>4 m/s OR mean aortic gradient \>40 mmHg, AND EOA ≥0.8 cm2, and DVI \<0.25 3. Peak aortic velocity ≤4 m/s and mean aortic gradient ≤ 40 mmHg, AND EOA \<0.8 cm2, and DVI \<0.25 Regurgitation (moderate or severe) Any of the following: 1. Moderate or Severe Total Regurgitation 2. Moderate or Severe Paravalvular Regurgitation 3. Moderate or Severe Transvalvular Regurgitation
Time frame: 1 year
Population: Implanted
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Randomized Controlled Trial - Medtronic TAVR Systems | Valve-related Dysfunction (Moderate or Severe Stenosis or Regurgitation) at 1 Year, Randomized Controlled Trial | Moderate or severe stenosis | 0.2 Percent of participants |
| Randomized Controlled Trial - Medtronic TAVR Systems | Valve-related Dysfunction (Moderate or Severe Stenosis or Regurgitation) at 1 Year, Randomized Controlled Trial | Moderate or severe regurgitation | 4.3 Percent of participants |
| Randomized Controlled Trial - SAVR | Valve-related Dysfunction (Moderate or Severe Stenosis or Regurgitation) at 1 Year, Randomized Controlled Trial | Moderate or severe stenosis | 0.4 Percent of participants |
| Randomized Controlled Trial - SAVR | Valve-related Dysfunction (Moderate or Severe Stenosis or Regurgitation) at 1 Year, Randomized Controlled Trial | Moderate or severe regurgitation | 1.3 Percent of participants |
Secondary
Valve-related Dysfunction Requiring Repeat Procedure at 1 Year
The rate of valve-related dysfunction requiring repeat procedure at 1 year
Time frame: 1 year
Population: Randomized Controlled Trial - As treated set Continued Access Study - Attempted implant set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Randomized Controlled Trial - Medtronic TAVR Systems | Valve-related Dysfunction Requiring Repeat Procedure at 1 Year | 0.6 Percent of participants (K-M rate) |
| Randomized Controlled Trial - SAVR | Valve-related Dysfunction Requiring Repeat Procedure at 1 Year | 0.4 Percent of participants (K-M rate) |
| Continued Access Study - Medtronic TAVR Systems | Valve-related Dysfunction Requiring Repeat Procedure at 1 Year | 0.8 Percent of participants (K-M rate) |
Other Pre-specified
Efficacy: Device Success Rate
Assessment of procedural effectiveness by meeting all of the following device success criteria: * Absence of procedural mortality, AND * Correct positioning of a single prosthetic heart valve into the proper anatomical location, AND * Absence of moderate or severe total prosthetic valve regurgitation (at 18 hours to 7 days)
Time frame: Hospital discharge or 7 days post-procedure (whichever occurs first)
Population: Randomized Controlled Trial - Implanted set. Per the Clinical Investigational Plan, the incidence estimate is provided for the TAVR group only.~Continued Access Study - Attempted implant set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Randomized Controlled Trial - Medtronic TAVR Systems | Efficacy: Device Success Rate | 85.3 Percent of participants |
| Randomized Controlled Trial - SAVR | Efficacy: Device Success Rate | 98.1 Percent of participants |
Other Pre-specified
Health-related Quality of Life as Assessed by European QoL (EQ-5D) at 1 Year, Randomized Controlled Trial
Quality of life summary scores and change from baseline using the following measures: EQ-5D: Measures 5 domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that can be converted to utilities using an algorithm. Utilities range from 0 to 1, with 1 representing perfect health, and 0 corresponding to the worst imaginable health state
Time frame: 1 year
Population: As treated set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Randomized Controlled Trial - Medtronic TAVR Systems | Health-related Quality of Life as Assessed by European QoL (EQ-5D) at 1 Year, Randomized Controlled Trial | EQ-5D Index Score at 1 year | 0.81 Score on a scale | Standard Deviation 0.21 |
| Randomized Controlled Trial - Medtronic TAVR Systems | Health-related Quality of Life as Assessed by European QoL (EQ-5D) at 1 Year, Randomized Controlled Trial | 1 year change from baseline EQ-5D Index Score | 0.09 Score on a scale | Standard Deviation 0.24 |
| Randomized Controlled Trial - SAVR | Health-related Quality of Life as Assessed by European QoL (EQ-5D) at 1 Year, Randomized Controlled Trial | EQ-5D Index Score at 1 year | 0.81 Score on a scale | Standard Deviation 0.19 |
| Randomized Controlled Trial - SAVR | Health-related Quality of Life as Assessed by European QoL (EQ-5D) at 1 Year, Randomized Controlled Trial | 1 year change from baseline EQ-5D Index Score | 0.08 Score on a scale | Standard Deviation 0.24 |
Other Pre-specified
Hemodynamic Performance Metrics by Doppler Echocardiography at 1 Year, Randomized Controlled Trial Effective Orifice Area (EOA) at 1 Year
Reporting of prosthetic valve hemodynamic performance by EOA
Time frame: 1 year
Population: Implanted
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized Controlled Trial - Medtronic TAVR Systems | Hemodynamic Performance Metrics by Doppler Echocardiography at 1 Year, Randomized Controlled Trial Effective Orifice Area (EOA) at 1 Year | 2.23 cm2 | Standard Deviation 0.63 |
| Randomized Controlled Trial - SAVR | Hemodynamic Performance Metrics by Doppler Echocardiography at 1 Year, Randomized Controlled Trial Effective Orifice Area (EOA) at 1 Year | 1.96 cm2 | Standard Deviation 0.57 |
Other Pre-specified
Hemodynamic Performance Metrics by Doppler Echocardiography at 1 Year, Randomized Controlled Trial Mean Aortic Gradient at 1 Year
Reporting of prosthetic valve hemodynamic performance by transvalvular mean aortic gradient
Time frame: 1 year
Population: Implanted
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized Controlled Trial - Medtronic TAVR Systems | Hemodynamic Performance Metrics by Doppler Echocardiography at 1 Year, Randomized Controlled Trial Mean Aortic Gradient at 1 Year | 8.74 mmHG | Standard Deviation 3.58 |
| Randomized Controlled Trial - SAVR | Hemodynamic Performance Metrics by Doppler Echocardiography at 1 Year, Randomized Controlled Trial Mean Aortic Gradient at 1 Year | 11.27 mmHG | Standard Deviation 4.81 |
Other Pre-specified
Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Total Prosthetic Valve Regurgitation at 1 Year, Randomized Controlled Trial
Reporting of prosthetic valve hemodynamic performance by degree of total prosthetic valve regurgitation
Time frame: 1 year
Population: Implanted
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Randomized Controlled Trial - Medtronic TAVR Systems | Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Total Prosthetic Valve Regurgitation at 1 Year, Randomized Controlled Trial | Trace | 23.5 Percent of participants |
| Randomized Controlled Trial - Medtronic TAVR Systems | Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Total Prosthetic Valve Regurgitation at 1 Year, Randomized Controlled Trial | None | 39.4 Percent of participants |
| Randomized Controlled Trial - Medtronic TAVR Systems | Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Total Prosthetic Valve Regurgitation at 1 Year, Randomized Controlled Trial | Mild/Mild to Moderate | 32.9 Percent of participants |
| Randomized Controlled Trial - Medtronic TAVR Systems | Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Total Prosthetic Valve Regurgitation at 1 Year, Randomized Controlled Trial | Moderate/Moderate to Severe | 4.1 Percent of participants |
| Randomized Controlled Trial - Medtronic TAVR Systems | Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Total Prosthetic Valve Regurgitation at 1 Year, Randomized Controlled Trial | Severe | 0.1 Percent of participants |
| Randomized Controlled Trial - SAVR | Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Total Prosthetic Valve Regurgitation at 1 Year, Randomized Controlled Trial | Severe | 0.0 Percent of participants |
| Randomized Controlled Trial - SAVR | Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Total Prosthetic Valve Regurgitation at 1 Year, Randomized Controlled Trial | Moderate/Moderate to Severe | 1.3 Percent of participants |
| Randomized Controlled Trial - SAVR | Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Total Prosthetic Valve Regurgitation at 1 Year, Randomized Controlled Trial | Mild/Mild to Moderate | 7.2 Percent of participants |
| Randomized Controlled Trial - SAVR | Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Total Prosthetic Valve Regurgitation at 1 Year, Randomized Controlled Trial | None | 72.2 Percent of participants |
| Randomized Controlled Trial - SAVR | Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Total Prosthetic Valve Regurgitation at 1 Year, Randomized Controlled Trial | Trace | 19.3 Percent of participants |
Other Pre-specified
New York Heart Association (NYHA) Functional Classification at 1 Year, Randomized Controlled Trial
Reporting of NYHA classification at 1 year 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: 1 year
Population: As treated set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Randomized Controlled Trial - Medtronic TAVR Systems | New York Heart Association (NYHA) Functional Classification at 1 Year, Randomized Controlled Trial | NYHA Class II | 15.8 Percent of participants |
| Randomized Controlled Trial - Medtronic TAVR Systems | New York Heart Association (NYHA) Functional Classification at 1 Year, Randomized Controlled Trial | NYHA Class IV | 0.4 Percent of participants |
| Randomized Controlled Trial - Medtronic TAVR Systems | New York Heart Association (NYHA) Functional Classification at 1 Year, Randomized Controlled Trial | NYHA Class III | 1.1 Percent of participants |
| Randomized Controlled Trial - Medtronic TAVR Systems | New York Heart Association (NYHA) Functional Classification at 1 Year, Randomized Controlled Trial | Died prior to visit | 2.1 Percent of participants |
| Randomized Controlled Trial - Medtronic TAVR Systems | New York Heart Association (NYHA) Functional Classification at 1 Year, Randomized Controlled Trial | NYHA Class I | 80.6 Percent of participants |
| Randomized Controlled Trial - SAVR | New York Heart Association (NYHA) Functional Classification at 1 Year, Randomized Controlled Trial | Died prior to visit | 3.0 Percent of participants |
| Randomized Controlled Trial - SAVR | New York Heart Association (NYHA) Functional Classification at 1 Year, Randomized Controlled Trial | NYHA Class I | 79.5 Percent of participants |
| Randomized Controlled Trial - SAVR | New York Heart Association (NYHA) Functional Classification at 1 Year, Randomized Controlled Trial | NYHA Class II | 15.7 Percent of participants |
| Randomized Controlled Trial - SAVR | New York Heart Association (NYHA) Functional Classification at 1 Year, Randomized Controlled Trial | NYHA Class III | 1.4 Percent of participants |
| Randomized Controlled Trial - SAVR | New York Heart Association (NYHA) Functional Classification at 1 Year, Randomized Controlled Trial | NYHA Class IV | 0.3 Percent of participants |