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Supra-Annular vs. Annular ValvEs for Small Annuli

NCT04372381 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2026-07-24

No results posted yet for this study

Summary

Open-label, prospective randomized comparison of Supra-annular valves (Medtronic Evolut Pro) vs. annular valves (Edwards Sapien Ultra) for small annuli (≤23 mm)

Conditions

  • Aortic Valve Stenosis
  • Implantation, Heart Valve Prosthesis

Interventions

DEVICE

Transcatheter aortic valve replacement (Edwards Sapien Ultra or Medtronic Evolut Pro

Treatment of aortic valve stenosis using transcatheter aortic valve replacement

Sponsors & Collaborators

  • Corewell Health East

    collaborator OTHER

  • Henry Ford Health System

    collaborator OTHER

  • University of Arizona

    lead OTHER

Principal Investigators

  • Marvin Eng, MD · University of Arizona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-12
Primary Completion
2025-04-30
Completion
2025-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04372381 on ClinicalTrials.gov