RecruitingNCT05603026

MRI-TAVR

MRI in Transcatheter Aortic Valve Replacement Patients

University Hospitals Cleveland Medical CenterOne US siteView on ClinicalTrials.gov

AI Description

The hypothesis is that SEV result in superior valvular hemodynamics (more pronounced during exercise) and exercise capacity relative to BEV. Furthermore, the hypothesis is that stress CMR will be able to demonstrate differences in these hemodynamic parameters. CMR will also provide refined assessment of paravalvular leak and its impact on ventricular function and on clinical outcomes.

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Who can join
adult, older adult
Participants
90
Expected completion
2026-12-30
Funded by
other

Conditions studied

Aortic Valve Stenosis

What is being tested

  • DEVICE: Balloon-expanding valve (Edwards Sapien 3 Ultra RESILIA)
  • DEVICE: Self-expanding valve (Medtronic Evolut FX)

What it measures

  • Effective orifice area (EOA), Change in effective orifice area (EOA) assessed by CMR between baseline and 1-year follow up (cm2), Baseline, 30-days and 1-year
  • Mean gradient, Mean AV gradient assessed by CMR (mmHg), 1-year
  • Peak gradient, Mean AV gradient assessed by CMR (mmHg), 1-year

Centers Participating

These centers are participating in this study. Reach out to them directly to learn more.

Data Sources and Methodology

Registry entry updated 2025-12-17

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