NCT05603026 MRI in Transcatheter Aortic Valve Replacement Patients
| NCT ID | NCT05603026 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospitals Cleveland Medical Center |
| Condition | Aortic Valve Stenosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2023-11-21 |
| Primary Completion | 2026-12-30 |
Trial Parameters
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Brief 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 Criteria
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.