SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2023

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+ 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 – Edwards SAPIEN 3 and SAPIEN 3 Ultra THV Systems

Interventions

  • Device: Medtronic Evolut PRO or Evolut PRO+ TAV Systems
    • TAVR treatment with Medtronic Evolut PRO or PRO+ System
  • Device: Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems
    • TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System

Arms, Groups and Cohorts

  • Experimental: 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.
  • Experimental: 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.

Clinical Trial Outcome Measures

Primary Measures

  • Mortality, disabling stroke or rehospitalization
    • Time Frame: 12 months
    • Percentage of participants with all-cause mortality, disabling stroke, or rehospitalization (valve-related or worsening of heart failure).
  • Bioprosthetic Valve Dysfunction (BVD)
    • Time Frame: 12 months
    • Percentage of participants with BVD (hemodynamic structural valve dysfunction, non-structural valve dysfunction, thrombosis, endocarditis, or aortic valve re-intervention) at 12 months.

Secondary Measures

  • Percentage of participants with BVD in female subjects
    • Time Frame: 12 months
  • Percentage of participants with Hemodynamic Structural Valve Dysfunction (HSVD)
    • Time Frame: 12 months
  • Aortic valve mean gradient as a continuous variable
    • Time Frame: 12 months
  • Effective Orifice Area (EOA) as a continuous variable
    • Time Frame: 12 months
  • Rate of moderate or severe prothesis-patient mismatch (PPM)
    • Time Frame: 30 days

Participating in This Clinical Trial

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+ 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 – 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+ 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Medtronic Cardiovascular
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Howard Herrmann, MD, Principal Investigator, University of Pennsylvania, United States
    • Roxanna Mehran, MD, Principal Investigator, Mount Sinai School of Medicine, United States
    • Didier Tchétché, MD, Principal Investigator, Clinique Pasteur Toulouse, France
  • Overall Contact(s)
    • SMART Trial Clinical Study Team, 763-514-4000, rs.smarttrial@medtronic.com

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