The trial is taking place at:
A

AOU Integrata Verona | AOU Integrata Verona Oncology Unit

Veeva-enabled site

SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial (SMART)

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Covidien

Status

Active, not recruiting

Conditions

Aortic Valve Replacement
Aortic Valve Stenosis
Symptomatic Aortic Stenosis

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT04722250
MDT20023EVR012

Details and patient eligibility

About

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.

Full 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.

Enrollment

716 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

716 participants in 2 patient groups

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

Trial contacts and locations

92

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Data sourced from clinicaltrials.gov

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