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MRI in Transcatheter Aortic Valve Replacement Patients

Comparison of Hemodynamic Performance of Transcatheter Aortic Valve Replacement With Supra-Annular Self-Expanding Versus Balloon-Expandable Valves Assessed by Exercise Cardiovascular Magnetic Resonance

Who can join

Ages 18 to 105 · All sexes

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

About the study

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.

What is being tested

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

Sponsor: University Hospitals Cleveland Medical Center · Participants: 90 · Started: Nov 21, 2023

Contact the study team

• Luis Dallan, MD · Phone: 216-844-1000
• LaStasha Cowan · Phone: 216-844-1000

Official record on ClinicalTrials.gov — NCT05603026

Locations in the U.S.

Conditions

• Aortic Valve Stenosis

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.