Aortic Valve Replacement, Aortic Valve Stenosis, Symptomatic Aortic Stenosis
Conditions
Brief summary
The purpose of this trial is to generate clinical evidence on valve safety and performance of self-expanding (SE) versus balloon-expandable (BE) transcatheter aortic valve replacement (TAVR) in subjects with a small aortic annulus and symptomatic severe native aortic stenosis. Additionally, a stress echocardiography sub-study will be conducted as part of the SMART Trial at select sites. The purpose of the sub-study is to evaluate performance of SE versus BE TAVR in subjects with a small aortic annulus and symptomatic severe native aortic stenosis after undergoing exercise stress echocardiographic testing.
Detailed description
This is a prospective, multi-center, international, randomized controlled, post-market trial. The primary objectives of the trial are to demonstrate clinical non-inferiority and hemodynamic superiority of the Evolut PRO/PRO+/FX System when compared to subjects treated with the SAPIEN 3/3 Ultra System at 12 months post-procedure. Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE Transcatheter Aortic Valve (TAV) or an Edwards BE Transcatheter Heart Valve (THV). Data will be collected at pre- and post-procedure, at discharge, at 30 days, and once a year until the 5-year follow-up is completed. Product Names: * Medtronic Evolut PRO and Evolut PRO+ TAV Systems, Evolut FX System (Commercially available in the United States and may be used upon commercial availability in Canada.) * Edwards SAPIEN 3 and SAPIEN 3 Ultra THV Systems The exercise stress echocardiographic testing at select SMART Trial sites seeks to evaluate the performance of the prosthetic aortic valve during exercise. The stress echocardiogram assessment will be conducted as part of the 12-month visit for participating subjects.
Interventions
DEVICEMedtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems
TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)
DEVICEEdwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems
TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System
Sponsors
Medtronic Cardiovascular
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Heart Team agrees that the subject is deemed symptomatic and is a candidate for transcatheter aortic valve replacement (TAVR) * Subject has a predicted risk of operative mortality \< 15% as determined by the local Heart Team * Subject has severe aortic stenosis as determined by transthoracic echocardiography (TTE) at rest * Subject has a small aortic annulus as determined by Multi-detector computed tomography (MDCT) * Subject's anatomy is appropriate for both Medtronic Evolut PRO/PRO+/FX TAV and Edwards SAPIEN 3/3 Ultra TAV * Subject's anatomy is suitable for TAVR via transfemoral vessel access * Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits
Exclusion criteria
* Estimated life expectancy of fewer than 2 years * Multivessel coronary artery disease with a Syntax score \>32 and/or unprotected left main coronary artery(Syntax score calculation is not required for patients with history of previous revascularization if repeat revascularization is not planned). * Participating in another trial that may influence the outcome of this trial * Need for an emergent procedure for any reason * Contraindicated for treatment with the Evolut PRO/PRO+/FX and Edwards SAPIEN 3/3 Ultra TAV in accordance with the Instructions for Use * 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 * Pregnant, nursing, or planning to be pregnant * Subject is less than the legal age of consent, legally incompetent, unable to provide his/her own informed consent, or otherwise vulnerable * Subject has an active COVID-19 infection or relevant history of COVID-19 * Previous aortic valve replacement
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality, Disabling Stroke or Heart Failure Rehospitalization | 12 months | Percentage of participants with all-cause mortality, disabling stroke, or heart failure rehospitalization. |
| Bioprosthetic Valve Dysfunction (BVD) | 12 months | Percentage of participants with BVD as determined by echocardiography (hemodynamic structural valve dysfunction (aortic valve no longer works properly as measured by hemodynamic mean gradient ≥ 20mmHg), non-structural valve dysfunction (severe prosthesis-patient mismatch (valve is too small) and/or ≥ moderate total aortic regurgitation (backward flow of blood)), thrombosis (formation of a blood clot), endocarditis (inflammation of the endocardium - the inner lining of the heart chambers and valves), or aortic valve re-intervention (a follow-up procedure to fix or replace the aortic prosthetic valve)) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With BVD in Female Subjects | 12 months | Percentage of participants with BVD as determined by echocardiography (hemodynamic structural valve dysfunction (aortic valve no longer works properly as measured by hemodynamic mean gradient ≥ 20mmHg), non-structural valve dysfunction (severe prosthesis-patient mismatch (valve is too small) and/or ≥ moderate total aortic regurgitation (backward flow of blood)), thrombosis (formation of a blood clot), endocarditis (inflammation of the endocardium - the inner lining of the heart chambers and valves), or aortic valve re-intervention (a follow-up procedure to fix or replace the aortic prosthetic valve)). |
| Percentage of Participants With Hemodynamic Structural Valve Dysfunction (HSVD) | 12 months | HSVD is defined as hemodynamic mean gradient ≥ 20mmHg on any echocardiogram after implant procedure. |
| Hemodynamic Mean Gradient as Continuous Variable | 12 months | Mean aortic gradient as measured by echocardiogram at the 12-month visit. |
| Effective Orifice Area (EOA) as a Continuous Variable | 12 months | Effective Orifice Area (EOA) as measured by echocardiogram at the 12-month visit. |
| Rate of Moderate or Severe Prothesis-patient Mismatch (PPM) | 30 days | Moderate or severe PPM will be defined as follows: For subjects with BMI \< 30 kg/m2 * Moderate PPM: EOAI = 0.85 - 0.65 cm2/m2 * Severe PPM: EOAI = ≤ 0.65 cm2/m2 For subjects with BMI ≥ 30 kg/m2 * Moderate PPM: EOAI = 0.70 - 0.55 cm2/m2 * Severe PPM: EOAI = ≤ 0.55 cm2/m2 |
Countries
Canada, Denmark, Finland, France, Germany, Israel, Italy, Netherlands, Portugal, Spain, Switzerland, United Kingdom, United States
Contacts
PRINCIPAL_INVESTIGATORHoward Herrmann, MD
University of Pennsylvania, United States
PRINCIPAL_INVESTIGATORRoxana Mehran, MD
Mount Sinai School of Medicine, United States
PRINCIPAL_INVESTIGATORDidier Tchétché, MD
Clinique Pasteur Toulouse, France
Participant flow
Pre-assignment details
A total of 1103 subjects were enrolled (consented): 212 subjects were exited prior to screening,154 exited the study prior to randomization, 737\* subjects were randomized. \*Notes: One additional subject was inadvertently randomized but was withdrawn after screening disapproval. -716 subjects had an attempted procedure, these subjects are the As-Treated set and are analyzed according to their first attempted device. This includes both administrative and procedural crossovers as shown below.
Participants by arm
| Arm | Count |
|---|---|
| Medtronic Self-Expanding TAV Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.
Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems: TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available) | 355 |
| Edwards Balloon-Expandable THV Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.
Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems: TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System | 361 |
| Total | 716 |
Baseline characteristics
| Characteristic | Total | Medtronic Self-Expanding TAV | Edwards Balloon-Expandable THV |
|---|---|---|---|
| Age, Continuous | 80.2 years STANDARD_DEVIATION 6.2 | 80.1 years STANDARD_DEVIATION 6.3 | 80.3 years STANDARD_DEVIATION 6.1 |
| Body Surface Area | 1.8 m^2 STANDARD_DEVIATION 0.2 | 1.8 m^2 STANDARD_DEVIATION 0.2 | 1.8 m^2 STANDARD_DEVIATION 0.2 |
| Ethnicity (NIH/OMB) Ethnicity of US Only, Unknown number also includes outside of US. Hispanic or Latino | 9 Participants | 4 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Ethnicity of US Only, Unknown number also includes outside of US. Not Hispanic or Latino | 345 Participants | 171 Participants | 174 Participants |
| Ethnicity (NIH/OMB) Ethnicity of US Only, Unknown number also includes outside of US. Unknown or Not Reported | 362 Participants | 180 Participants | 182 Participants |
| NYHA (Baseline) NYHA I | 10 Participants | 4 Participants | 6 Participants |
| NYHA (Baseline) NYHA II | 408 Participants | 197 Participants | 211 Participants |
| NYHA (Baseline) NYHA III | 294 Participants | 150 Participants | 144 Participants |
| NYHA (Baseline) NYHA IV | 4 Participants | 4 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 19 Participants | 7 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 364 Participants | 182 Participants | 182 Participants |
| Race (NIH/OMB) White | 326 Participants | 161 Participants | 165 Participants |
| Region of Enrollment Canada | 75 Participants | 34 Participants | 41 Participants |
| Region of Enrollment Denmark | 7 Participants | 3 Participants | 4 Participants |
| Region of Enrollment Finland | 4 Participants | 2 Participants | 2 Participants |
| Region of Enrollment France | 31 Participants | 16 Participants | 15 Participants |
| Region of Enrollment Germany | 116 Participants | 59 Participants | 57 Participants |
| Region of Enrollment Israel | 13 Participants | 6 Participants | 7 Participants |
| Region of Enrollment Italy | 36 Participants | 18 Participants | 18 Participants |
| Region of Enrollment Netherlands | 7 Participants | 4 Participants | 3 Participants |
| Region of Enrollment Portugal | 7 Participants | 4 Participants | 3 Participants |
| Region of Enrollment Spain | 15 Participants | 7 Participants | 8 Participants |
| Region of Enrollment Switzerland | 2 Participants | 1 Participants | 1 Participants |
| Region of Enrollment United Kingdom | 36 Participants | 18 Participants | 18 Participants |
| Region of Enrollment United States | 367 Participants | 183 Participants | 184 Participants |
| Sex/Gender, Customized Gender Female | 621 Participants | 312 Participants | 309 Participants |
| Sex/Gender, Customized Gender Male | 95 Participants | 43 Participants | 52 Participants |
| STS Category <3 | 373 Participants | 182 Participants | 191 Participants |
| STS Category [3,5) | 245 Participants | 122 Participants | 123 Participants |
| STS Category [5,8) | 72 Participants | 37 Participants | 35 Participants |
| STS Category ≥ 8 | 26 Participants | 14 Participants | 12 Participants |
| STS Category Count of Participants | 716 Participants | 355 Participants | 361 Participants |
| STS Score | 3.3 Percent STANDARD_DEVIATION 1.8 | 3.3 Percent STANDARD_DEVIATION 1.9 | 3.2 Percent STANDARD_DEVIATION 1.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 43 / 355 | 40 / 361 | 2 / 4 |
| other Total, other adverse events | 0 / 355 | 0 / 361 | 0 / 4 |
| serious Total, serious adverse events | 210 / 355 | 207 / 361 | 4 / 4 |
Outcome results
Primary
Bioprosthetic Valve Dysfunction (BVD)
Percentage of participants with BVD (hemodynamic structural valve dysfunction (hemodynamic mean gradient ≥ 20mmHg), non-structural valve dysfunction (severe prosthesis-patient mismatch and/or ≥ moderate total aortic regurgitation), thrombosis, endocarditis, or aortic valve re-intervention) at 12 months.
Time frame: 12 months
Population: Implanted set (all subjects implanted with TAVR during index procedure according to last device implanted). \*Note that a subject who is first attempted with one device then subsequently implanted with the other device will be analyzed according to the last implanted device.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Medtronic Self-Expanding TAV | Bioprosthetic Valve Dysfunction (BVD) | 9.4 Percent of Participants (K-M Rate) |
| Edwards Balloon-Expandable THV | Bioprosthetic Valve Dysfunction (BVD) | 41.6 Percent of Participants (K-M Rate) |
p-value: <0.00195% CI: [-38.7, -25.6]z-test on Kaplan-Meier percentages
Primary
Mortality, Disabling Stroke or Heart Failure Rehospitalization
Percentage of participants with all-cause mortality, disabling stroke, or heart failure rehospitalization.
Time frame: 12 months
Population: As Treated set (all subjects with attempted TAVR procedure according to first device used)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Medtronic Self-Expanding TAV | Mortality, Disabling Stroke or Heart Failure Rehospitalization | 9.4 Percent of Participants (K-M Rate) |
| Edwards Balloon-Expandable THV | Mortality, Disabling Stroke or Heart Failure Rehospitalization | 10.6 Percent of Participants (K-M Rate) |
p-value: <0.00190% CI: [-4.9, 2.5]z-test on Kaplan-Meier percentages
Secondary
Effective Orifice Area (EOA) as a Continuous Variable
Effective Orifice Area (EOA) as measured by echocardiogram at the 12-month visit.
Time frame: 12 months
Population: Implanted set (all subjects implanted with TAVR during index procedure according to last device implanted)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medtronic Self-Expanding TAV | Effective Orifice Area (EOA) as a Continuous Variable | 1.98 cm2 | Standard Deviation 0.47 |
| Edwards Balloon-Expandable THV | Effective Orifice Area (EOA) as a Continuous Variable | 1.50 cm2 | Standard Deviation 0.35 |
Secondary
Hemodynamic Mean Gradient as Continuous Variable
Mean aortic gradient as measured by echocardiogram at the 12-month visit.
Time frame: 12 months
Population: Implanted set (all subjects implanted with TAVR during index procedure according to last device implanted)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medtronic Self-Expanding TAV | Hemodynamic Mean Gradient as Continuous Variable | 7.7 mmHg | Standard Deviation 4 |
| Edwards Balloon-Expandable THV | Hemodynamic Mean Gradient as Continuous Variable | 15.7 mmHg | Standard Deviation 6.7 |
Secondary
Percentage of Participants With BVD in Female Subjects
Time frame: 12 months
Population: Implanted set (all subjects implanted with TAVR during index procedure according to last device implanted) \*Note that a subject who is first attempted with one device then subsequently implanted with the other device will be analyzed according to the last implanted device.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Medtronic Self-Expanding TAV | Percentage of Participants With BVD in Female Subjects | 8.4 percentage of participants (K-M rate) |
| Edwards Balloon-Expandable THV | Percentage of Participants With BVD in Female Subjects | 41.8 percentage of participants (K-M rate) |
Secondary
Percentage of Participants With Hemodynamic Structural Valve Dysfunction (HSVD)
HSVD is defined as hemodynamic mean gradient ≥ 20mmHg on any echocardiogram after implant procedure.
Time frame: 12 months
Population: Implanted set (all subjects implanted with TAVR during index procedure according to last device implanted) \*Note that a subject who is first attempted with one device then subsequently implanted with the other device will be analyzed according to the last implanted device.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Medtronic Self-Expanding TAV | Percentage of Participants With Hemodynamic Structural Valve Dysfunction (HSVD) | 3.2 percentage of participants (K-M rate) |
| Edwards Balloon-Expandable THV | Percentage of Participants With Hemodynamic Structural Valve Dysfunction (HSVD) | 32.2 percentage of participants (K-M rate) |
Secondary
Rate of Moderate or Severe Prothesis-patient Mismatch (PPM)
Moderate or severe PPM will be defined as follows: For subjects with BMI \< 30 kg/m2 * Moderate PPM: EOAI = 0.85 - 0.65 cm2/m2 * Severe PPM: EOAI = ≤ 0.65 cm2/m2 For subjects with BMI ≥ 30 kg/m2 * Moderate PPM: EOAI = 0.70 - 0.55 cm2/m2 * Severe PPM: EOAI = ≤ 0.55 cm2/m2
Time frame: 30 days
Population: Implanted set (all subjects implanted with TAVR during index procedure according to last device implanted)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Medtronic Self-Expanding TAV | Rate of Moderate or Severe Prothesis-patient Mismatch (PPM) | 28 Participants |
| Edwards Balloon-Expandable THV | Rate of Moderate or Severe Prothesis-patient Mismatch (PPM) | 104 Participants |
Other Pre-specified
6-minute Walk Test (6MWT) Change From Baseline
Time frame: 30 days
Population: As Treated set (all subjects with attempted TAVR procedure according to first device used)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medtronic Self-Expanding TAV | 6-minute Walk Test (6MWT) Change From Baseline | 25.5 Meters | Standard Deviation 97.3 |
| Edwards Balloon-Expandable THV | 6-minute Walk Test (6MWT) Change From Baseline | 38.1 Meters | Standard Deviation 86.7 |
Other Pre-specified
6-minute Walk Test (6MWT) Change From Baseline
Time frame: 12 Months
Population: As Treated set (all subjects with attempted TAVR procedure according to first device used)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medtronic Self-Expanding TAV | 6-minute Walk Test (6MWT) Change From Baseline | 39.5 Meters | Standard Deviation 100.5 |
| Edwards Balloon-Expandable THV | 6-minute Walk Test (6MWT) Change From Baseline | 33.8 Meters | Standard Deviation 94.8 |
Other Pre-specified
Aortic Valve Re-intervention Rate
Time frame: 30 days, 12 months
Population: As Treated set (all subjects with attempted TAVR procedure according to first device used)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Medtronic Self-Expanding TAV | Aortic Valve Re-intervention Rate | 30 Days | 0.6 percentage of participants (K-M rate) |
| Medtronic Self-Expanding TAV | Aortic Valve Re-intervention Rate | 12 Month | 0.9 percentage of participants (K-M rate) |
| Edwards Balloon-Expandable THV | Aortic Valve Re-intervention Rate | 30 Days | 0.3 percentage of participants (K-M rate) |
| Edwards Balloon-Expandable THV | Aortic Valve Re-intervention Rate | 12 Month | 0.6 percentage of participants (K-M rate) |
Other Pre-specified
Device Success
Device Success is defined as meeting all of the following: Freedom from mortality AND Correct positioning of a single prosthetic heart valve into the proper anatomical location AND Intended performance of the prosthetic heart valve (no prosthesis-patient mismatch (PPM) and mean aortic valve gradient \<20 mmHg or peak velocity \<3 m/s) AND No moderate or severe prosthetic valve regurgitation)
Time frame: 30 days
Population: As Treated set (all subjects with attempted TAVR procedure according to first device used)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Medtronic Self-Expanding TAV | Device Success | 248 Participants |
| Edwards Balloon-Expandable THV | Device Success | 189 Participants |
Other Pre-specified
Hospital Readmission Rate for Any Cause
Time frame: 30 days
Population: As Treated set (all subjects with attempted TAVR procedure according to first device used)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Medtronic Self-Expanding TAV | Hospital Readmission Rate for Any Cause | 8.6 percentage of participants (K-M rate) |
| Edwards Balloon-Expandable THV | Hospital Readmission Rate for Any Cause | 11.2 percentage of participants (K-M rate) |
Other Pre-specified
Incidence of an Early Safety Composite
Incidence of an early safety composite at 30 days defined as: * All-cause mortality * All stroke (disabling and non-disabling) * Life-threatening bleeding * Acute kidney injury-Stage 2 or 3 (including renal replacement therapy) * Coronary artery obstruction requiring intervention * Major vascular complication * Valve-related dysfunction requiring repeat procedure (BAV, TAVR, or SAVR)
Time frame: 30 days
Population: As Treated set (all subjects with attempted TAVR procedure according to first device used)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Medtronic Self-Expanding TAV | Incidence of an Early Safety Composite | 9.9 percentage of participants (K-M rate) |
| Edwards Balloon-Expandable THV | Incidence of an Early Safety Composite | 7.2 percentage of participants (K-M rate) |
Other Pre-specified
Incidence of Clinical Efficacy
Incidence of clinical efficacy (after 30 days) at 12 months defined as a composite of: * All-cause mortality * All stroke (disabling and non-disabling) * Requiring hospitalizations for valve-related symptoms or worsening congestive heart failure * NYHA class III or IV * Valve-related dysfunction (mean aortic valve gradient ≥20 mmHg, EOA ≤0.9-1.1 cm2 and/or Doppler velocity index (DVI) \<0. 35m/s, AND/OR moderate or severe prosthetic valve regurgitation)
Time frame: 12 months
Population: Implanted set (all subjects implanted with TAVR during index procedure according to last device implanted)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Medtronic Self-Expanding TAV | Incidence of Clinical Efficacy | 11.9 percentage of participants (K-M rate) |
| Edwards Balloon-Expandable THV | Incidence of Clinical Efficacy | 30.5 percentage of participants (K-M rate) |
Other Pre-specified
Mean Gradient ≥ 20 mmHg Based on Stress Echocardiogram
Mean gradient ≥ 20 mmHg based on stress echocardiogram at select sites.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Medtronic Self-Expanding TAV | Mean Gradient ≥ 20 mmHg Based on Stress Echocardiogram | 2 Participants |
| Edwards Balloon-Expandable THV | Mean Gradient ≥ 20 mmHg Based on Stress Echocardiogram | 14 Participants |
Other Pre-specified
New Pacemaker Implantation Rate
Note: This section is excluding subjects with pacemaker or ICD at baseline.
Time frame: 30 days, 12 months
Population: As Treated set (all subjects with attempted TAVR procedure according to first device used)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Medtronic Self-Expanding TAV | New Pacemaker Implantation Rate | 30 Days | 12.1 percentage of participants (K-M rate) |
| Medtronic Self-Expanding TAV | New Pacemaker Implantation Rate | 12-Month | 14.0 percentage of participants (K-M rate) |
| Edwards Balloon-Expandable THV | New Pacemaker Implantation Rate | 30 Days | 7.8 percentage of participants (K-M rate) |
| Edwards Balloon-Expandable THV | New Pacemaker Implantation Rate | 12-Month | 9.3 percentage of participants (K-M rate) |
Other Pre-specified
Percentage of Participants With Individual Clinical Endpoint Components Including Mortality, Disabling Stroke and Heart Failure Rehospitalization
Time frame: 12 months
Population: As Treated set (all subjects with attempted TAVR procedure according to first device used)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Medtronic Self-Expanding TAV | Percentage of Participants With Individual Clinical Endpoint Components Including Mortality, Disabling Stroke and Heart Failure Rehospitalization | All Cause Mortality | 5.1 percentage of participants (K-M rate) |
| Medtronic Self-Expanding TAV | Percentage of Participants With Individual Clinical Endpoint Components Including Mortality, Disabling Stroke and Heart Failure Rehospitalization | Disabling Stroke | 3.1 percentage of participants (K-M rate) |
| Medtronic Self-Expanding TAV | Percentage of Participants With Individual Clinical Endpoint Components Including Mortality, Disabling Stroke and Heart Failure Rehospitalization | Heart Failure Rehospitalization | 3.8 percentage of participants (K-M rate) |
| Edwards Balloon-Expandable THV | Percentage of Participants With Individual Clinical Endpoint Components Including Mortality, Disabling Stroke and Heart Failure Rehospitalization | All Cause Mortality | 5.9 percentage of participants (K-M rate) |
| Edwards Balloon-Expandable THV | Percentage of Participants With Individual Clinical Endpoint Components Including Mortality, Disabling Stroke and Heart Failure Rehospitalization | Disabling Stroke | 2.6 percentage of participants (K-M rate) |
| Edwards Balloon-Expandable THV | Percentage of Participants With Individual Clinical Endpoint Components Including Mortality, Disabling Stroke and Heart Failure Rehospitalization | Heart Failure Rehospitalization | 3.5 percentage of participants (K-M rate) |
Other Pre-specified
Quality of Life (QoL) Change From Baseline (EuroQol- 5 Dimension [EQ-5D])
EuroQol Group developed this Quality of Life (QOL) questionnaire referred to as EQ-5D that includes a descriptive system comprising five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The answers given to ED-5D can be converted into EQ-5D index and utility scores anchored at 0 for death and 1 for perfect health. The EQ-5D Index Score is calculated for each study participant and the descriptive statistical summary of the EQ-5D score for the study population is provided. The EQ-5D Visual Analog Scale (VAS) Score is a scale numbered 0 to 100 (0 is the worse health the patient can imagine and 100 is the best health the patient can imagine).\*
Time frame: 30 days
Population: As Treated set (all subjects with attempted TAVR procedure according to first device used)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Medtronic Self-Expanding TAV | Quality of Life (QoL) Change From Baseline (EuroQol- 5 Dimension [EQ-5D]) | EQ5D Index | 0.04 score on a scale | Standard Deviation 0.15 |
| Medtronic Self-Expanding TAV | Quality of Life (QoL) Change From Baseline (EuroQol- 5 Dimension [EQ-5D]) | EQ5D VAS | 8.1 score on a scale | Standard Deviation 19.1 |
| Edwards Balloon-Expandable THV | Quality of Life (QoL) Change From Baseline (EuroQol- 5 Dimension [EQ-5D]) | EQ5D Index | 0.05 score on a scale | Standard Deviation 0.15 |
| Edwards Balloon-Expandable THV | Quality of Life (QoL) Change From Baseline (EuroQol- 5 Dimension [EQ-5D]) | EQ5D VAS | 9.6 score on a scale | Standard Deviation 19.7 |
Other Pre-specified
Quality of Life (QoL) Change From Baseline (EuroQol- 5 Dimension [EQ-5D])
EuroQol Group developed this Quality of Life (QOL) questionnaire referred to as EQ-5D that includes a descriptive system comprising five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The answers given to ED-5D can be converted into EQ-5D index and utility scores anchored at 0 for death and 1 for perfect health. The EQ-5D Index Score is calculated for each study participant and the descriptive statistical summary of the EQ-5D score for the study population is provided. The EQ-5D Visual Analog Scale (VAS) Score is a scale numbered 0 to 100 (0 is the worse health the patient can imagine and 100 is the best health the patient can imagine).
Time frame: 12 Months
Population: As Treated set (all subjects with attempted TAVR procedure according to first device used)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Medtronic Self-Expanding TAV | Quality of Life (QoL) Change From Baseline (EuroQol- 5 Dimension [EQ-5D]) | EQ5D Index Score | 0.04 score on a scale | Standard Deviation 0.15 |
| Medtronic Self-Expanding TAV | Quality of Life (QoL) Change From Baseline (EuroQol- 5 Dimension [EQ-5D]) | EQ5D VAS | 8.4 score on a scale | Standard Deviation 20.1 |
| Edwards Balloon-Expandable THV | Quality of Life (QoL) Change From Baseline (EuroQol- 5 Dimension [EQ-5D]) | EQ5D Index Score | 0.02 score on a scale | Standard Deviation 0.15 |
| Edwards Balloon-Expandable THV | Quality of Life (QoL) Change From Baseline (EuroQol- 5 Dimension [EQ-5D]) | EQ5D VAS | 7.6 score on a scale | Standard Deviation 19.4 |
Other Pre-specified
Quality of Life (QoL) Change From Baseline (Kansas City Cardiomyopathy Questionnaire [KCCQ]
Kansas City Cardiomyopathy Questionnaire (KCCQ): Quantifies physical function, symptoms, social function, selfefficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. \*Note: This is the overall summary score for KCCQ.
Time frame: 30 days
Population: As Treated set (all subjects with attempted TAVR procedure according to first device used)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medtronic Self-Expanding TAV | Quality of Life (QoL) Change From Baseline (Kansas City Cardiomyopathy Questionnaire [KCCQ] | 18.0 score on a scale | Standard Deviation 19.4 |
| Edwards Balloon-Expandable THV | Quality of Life (QoL) Change From Baseline (Kansas City Cardiomyopathy Questionnaire [KCCQ] | 17.7 score on a scale | Standard Deviation 19.6 |
Other Pre-specified
Quality of Life (QoL) Change From Baseline (Kansas City Cardiomyopathy Questionnaire [KCCQ])
Kansas City Cardiomyopathy Questionnaire (KCCQ): Quantifies physical function, symptoms, social function, selfefficacy 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: 12 Months
Population: As Treated set (all subjects with attempted TAVR procedure according to first device used)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medtronic Self-Expanding TAV | Quality of Life (QoL) Change From Baseline (Kansas City Cardiomyopathy Questionnaire [KCCQ]) | 20.3 score on a scale | Standard Deviation 20.3 |
| Edwards Balloon-Expandable THV | Quality of Life (QoL) Change From Baseline (Kansas City Cardiomyopathy Questionnaire [KCCQ]) | 17.6 score on a scale | Standard Deviation 19.4 |