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Valve Hemodynamic Optimization Based on Doppler-Echocardiography vs Catheterization Measurements Following ViV TAVR

RecruitingNAAges 18 Years - anyAllInstitut universitaire de cardiologie et de pneum…
NCT05459233 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Data on valve performance following ViV-TAVR has usually been obtained with the use of Doppler-echocardiography. However, some reports have shown significant discordances in the evaluation of mean transvalvular gradient between echocardiography and catheterization, with an overestimation of the real gradient with echo (vs. cath) in most cases. Thus, the incidence of procedural-device failure may be lower than that reported in the ViV-TAVR literature,

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients with surgical aortic bioprosthetic valve failure defined as severe aortic stenosis and/or regurgitation approved for a valve-in-valve procedure by the Heart Team * Surgical stented bioprosthetic valve (label size ≤25 mm) * TAVR with the SAPIEN 3 Ultra valve Exclusion Criteria: * Stentless or sutureless surgical valves * Trifecta bioprosthesis * Hancock II bioprosthesis * High-risk of coronary obstruction (defined either as a virtual transcatheter valve - coronary distance as evaluated by CT \<4 mm or based on the criterion of the heart team responsible for the procedure). * Impossibility to obtain written informed consent
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What it tests

  • Doppler-echocardiography
  • Invasive hemodynamic measurements
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Where

7 sites
University of California
San Francisco, United States
South Broward Hospital Disctrict D/B/A Memorial Healthcare System
Hollywood, United States
William Beaumont Hospital
Royal Oak, United States
Mayo Clinic
Rochester, United States
St-Joseph's Health INC
Syracuse, United States
The Christ Hospital Health Network
Cincinnati, United States
IUCPQ
Québec, Canada
🤝 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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