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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2023-11-21 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Guilherme Attizzani, MD
PRINCIPAL INVESTIGATOR
UH, Cleveland Medical Center
Frequently Asked Questions
Who can join the NCT05603026 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 105 Years, studying Aortic Valve Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05603026 currently recruiting?
Yes, NCT05603026 is actively recruiting participants. Contact the research team at luisdallan@yahoo.com for enrollment information.
Where is the NCT05603026 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT05603026 clinical trial?
NCT05603026 is sponsored by University Hospitals Cleveland Medical Center. The principal investigator is Guilherme Attizzani, MD at UH, Cleveland Medical Center. The trial plans to enroll 90 participants.