RecruitingNot Applicable

MRI in Transcatheter Aortic Valve Replacement Patients

United States90 participantsStarted 2023-11-21

Plain-language 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.

Who can participate

Age range18 Years – 105 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Effective orifice area (EOA)

Timeframe: Baseline, 30-days and 1-year

Mean gradient

Timeframe: 1-year

Peak gradient

Timeframe: 1-year

Trial details

NCT IDNCT05603026

SponsorUniversity Hospitals Cleveland Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-30

Contact for this trial

Luis Dallan, MD

216-844-1000 luisdallan@yahoo.com

View on ClinicalTrials.gov More Aortic Valve Stenosis trials