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MRI in Transcatheter Aortic Valve Replacement Patients

NCT05603026 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-12-17

No results posted yet for this study

Summary

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.

Conditions

  • Aortic Valve Stenosis

Interventions

DEVICE

Self-expanding valve (Medtronic Evolut FX)

Bioprothesis Medtronic Evolut FX supra-annular self-expanding valve

DEVICE

Balloon-expanding valve (Edwards Sapien 3 Ultra RESILIA)

Bioprosthesis Edwards Sapien 3 Ultra valve

Sponsors & Collaborators

  • University Hospitals Cleveland Medical Center

    lead OTHER

Principal Investigators

  • Guilherme Attizzani, MD · UH, Cleveland Medical Center

  • Sadeer Al-Kindi, MD · University Hospitals Cleveland Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
105 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-21
Primary Completion
2026-12-30
Completion
2026-12-30
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 NCT05603026 on ClinicalTrials.gov