Clinical trial Recruiting at 1 site Interventional Ages 18 to 105

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.

More Aortic Valve Stenosis trials

Quick facts

Study typeInterventional
Ages18 Years to 105 Years
SexAll
Enrollment90 (estimated)
SponsorUniversity Hospitals Cleveland Medical Center
Academic / other
Locations1 site (Cleveland, Ohio)
StatusRecruiting
StartedNovember 21, 2023
Main results expectedDecember 30, 2026
Study endsDecember 30, 2026
Registry record updatedDecember 17, 2025
Trial IDNCT05603026 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

  • 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

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.