Using MRI to assess heart valve replacement in patients with aortic stenosis
Official title: Comparison of Hemodynamic Performance of Transcatheter Aortic Valve Replacement With Supra-Annular Self-Expanding Versus Balloon-Expandable Valves Assessed by Exercise Cardiovascular Magnetic Resonance
Run by University Hospitals Cleveland Medical Center · NCT05603026 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 105 Years |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | University Hospitals Cleveland Medical Center Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Status | Recruiting |
| Started | November 21, 2023 |
| Main results expected | December 30, 2026 |
| Study ends | December 30, 2026 |
| Registry record updated | December 17, 2025 |
| Trial ID | NCT05603026 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with aortic valve stenosis who are scheduled for transfemoral TAVR.
✕Probably not a fit
Patients with permanent pacemakers, severe claustrophobia, or significant non-treated coronary artery disease may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Previous studies have indicated favorable hemodynamics with self-expanding valves, but this specific approach using CMR for assessment is relatively novel.
Who can join: the full rules
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 it's running
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Transcatheter Aortic Valve Replacement Registry for Outcomes and Quality Monitoring
This registry collects information from hospitals about patients undergoing TAVR to see how care and outcomes compare to guidelines and nationwide data.
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Vericiguat to slow calcific aortic valve narrowing
This trial tests whether vericiguat can slow the progression of mild-to-moderate calcific aortic valve stenosis compared with placebo.
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CHATEAU Registry: Real-world outcomes after TAVR
This registry collects real-world data from adults who had TAVR between 2021 and 2025 to see how they do over time and how valve performance holds up.
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Impact of TAVR on kidney function in people with aortic valve disease
This registry tests how trans-catheter aortic valve implantation affects kidney function and the risk of kidney injury in adults with aortic stenosis.
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Hydra THV Transfemoral Valve Implantation in Severe Aortic Stenosis
This registry tests how safely and effectively the Hydra THV works when implanted through the femoral artery in adults with severe symptomatic aortic stenosis.
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How the type of sedation affects recovery after TAVR
This study will test whether three common sedation approaches (propofol, dexmedetomidine, or midazolam with fentanyl) change how people recover on the first day after transfemoral TAVR.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.