RecruitingNot ApplicableNCT05603026

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

Sponsor

University Hospitals Cleveland Medical Center

Enrollment

90 participants

Start Date

Nov 21, 2023

Study Type

INTERVENTIONAL

Conditions

Aortic Valve Stenosis

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.

Eligibility

Min Age: 18 YearsMax Age: 105 Years

Inclusion Criteria3

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 Criteria8

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.