SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial
Overview
- Phase
- N/A
- Intervention
- Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems
- Conditions
- Symptomatic Aortic Stenosis
- Sponsor
- Medtronic Cardiovascular
- Enrollment
- 1103
- Locations
- 92
- Primary Endpoint
- Mortality, Disabling Stroke or Heart Failure Rehospitalization
- Status
- Active, Not Recruiting
- Last Updated
- 2 months ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
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.
Intervention: Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems
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.
Intervention: Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems
Outcomes
Primary Outcomes
Mortality, Disabling Stroke or Heart Failure Rehospitalization
Time Frame: 12 months
Percentage of participants with all-cause mortality, disabling stroke, or heart failure rehospitalization.
Bioprosthetic Valve Dysfunction (BVD)
Time Frame: 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 Outcomes
- Percentage of Participants With Hemodynamic Structural Valve Dysfunction (HSVD)(12 months)
- Hemodynamic Mean Gradient as Continuous Variable(12 months)
- Effective Orifice Area (EOA) as a Continuous Variable(12 months)
- Rate of Moderate or Severe Prothesis-patient Mismatch (PPM)(30 days)
- Percentage of Participants With BVD in Female Subjects(12 months)