MRI in Transcatheter Aortic Valve Replacement Patients

Recruiting now · Not applicable

Conditions studied: Aortic Valve Stenosis

In brief

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.

Key facts

Study ID

NCT05603026

Run by

University Hospitals Cleveland Medical Center

People needed

90

Starts

2023-11-21

Expected to finish

2026-12-30

Last updated by the study team

2025-12-17

Who can join

Age: 18 and older, up to 105. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aortic valve stenosis with clinical indication for valve replacement decided by a dedicated heart team;
• Planned transfemoral TAVR; 18 years of age or older;
• Able to give informed consent.

You may not qualify if…

• Patients with permanent pacemakers or implantable defibrillators;
• Patients with non-MRI safe implants;
• Severe claustrophobia;
• Inability or contraindication to perform exercise bike stress test;
• Arrhythmia which would prevent adequate cardiac gating, including atrial fibrillation;
• Reduced left ventricular systolic function (<40%);
• History of surgical aortic valve replacement or patients who undergo a valve-in-valve TAVR procedures;
• Significant non-treated coronary artery disease.

Where it is running

• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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