SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial

Not Applicable

Active, not recruiting

Conditions: Aortic Valve Replacement
Symptomatic Aortic Stenosis
Aortic Valve Stenosis

Interventions: Device: Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems
Device: Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Edwards Balloon-Expandable THV	Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems	Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.
Medtronic Self-Expanding TAV	Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems	Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.

Primary Outcome Measures

Name	Time	Method
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 (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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With BVD in Female Subjects	12 months
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

Locations (92): Scripps Memorial Hospital
🇺🇸
La Jolla, California, United States
Cedars Sinai Medical Center
🇺🇸
Los Angeles, California, United States
Sutter Health
🇺🇸
San Francisco, California, United States
Los Robles Hospital and Medical Center
🇺🇸
Thousand Oaks, California, United States
University of Colorado
🇺🇸
Aurora, Colorado, United States
Yale New Haven Hospital
🇺🇸
New Haven, Connecticut, United States
WHC Washington MedStar
🇺🇸
Washington, District of Columbia, United States
Morton Plant Hospital
🇺🇸
Clearwater, Florida, United States
HealthPark Medical Center
🇺🇸
Fort Myers, Florida, United States
University of Florida
🇺🇸
Gainesville, Florida, United States
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Scripps Memorial Hospital
🇺🇸La Jolla, California, United States