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MRI in Transcatheter Aortic Valve Replacement Patients

RecruitingNAAges 18 Years - 105 YearsAllUniversity Hospitals Cleveland Medical Center
NCT05603026 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Self-expanding valve (Medtronic Evolut FX)
  • Balloon-expanding valve (Edwards Sapien 3 Ultra RESILIA)
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Where

1 site
University Hospitals Cleveland Medical Center
Cleveland, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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