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MRI in Transcatheter Aortic Valve Replacement Patients
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.
Conditions:
🦠 Aortic Valve Stenosis
🗓️ Study Start (Actual) 21 November 2023
🗓️ Primary Completion (Estimated) 30 December 2024
✅ Study Completion (Estimated) 30 December 2024
👥 Enrollment (Estimated) 90
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Cleveland, Ohio, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 18 Years to 105 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 24 October 2022
  • First Submitted that Met QC Criteria 1 November 2022
  • First Posted 2 November 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 28 November 2023
  • Last Update Posted 29 November 2023
  • Last Verified November 2023
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