Using MRI to assess heart valve replacement in patients with aortic stenosis
Comparison of Hemodynamic Performance of Transcatheter Aortic Valve Replacement With Supra-Annular Self-Expanding Versus Balloon-Expandable Valves Assessed by Exercise Cardiovascular Magnetic Resonance
This study is testing if MRI can show how well different types of heart valves work during exercise in younger patients with aortic stenosis to help improve their recovery and quality of life after valve replacement.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 105 Years |
| Sex | All |
| Sponsor | University Hospitals Cleveland Medical Center Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT05603026 on ClinicalTrials.gov |
What this trial studies
This study investigates the hemodynamic performance of self-expanding and balloon-expanding valves in patients undergoing transcatheter aortic valve replacement (TAVR) for aortic valve stenosis. It aims to determine if cardiac magnetic resonance (CMR) imaging can reveal differences in valve performance during exercise, which may correlate with improved exercise capacity. The study will also evaluate the impact of paravalvular leaks on heart function and clinical outcomes. By focusing on younger, more active patients, the research seeks to enhance recovery and quality of life post-procedure.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with aortic valve stenosis who are scheduled for transfemoral TAVR.
Not a fit: Patients with permanent pacemakers, severe claustrophobia, or significant non-treated coronary artery disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved valve selection and management strategies that enhance exercise capacity and overall quality of life for patients with aortic stenosis.
How similar studies have performed: Previous studies have indicated favorable hemodynamics with self-expanding valves, but this specific approach using CMR for assessment is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cleveland, Ohio
- University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Guilherme Attizzani, MD — UH, Cleveland Medical Center
- Study coordinator: Luis Dallan, MD
- Email: luisdallan@yahoo.com
- Phone: 216-844-1000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.