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

RECRUITINGN/ASponsored by Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Actively Recruiting
PhaseN/A
SponsorInstitut universitaire de cardiologie et de pneumologie de Québec, University Laval
Started2023-01-11
Est. completion2025-09-01
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations6 sites
View on ClinicalTrials.gov →

NCT05459233

Summary

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,

Eligibility

Age: 18 Years+Healthy volunteers accepted
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

Conditions4

Aortic Valve RegurgitationAortic Valve StenosisHeart DiseaseProsthesis Failure

Locations6 sites

University of California
San Francisco, California, 94143
Sammy Elmariah
South Broward Hospital Disctrict D/B/A Memorial Healthcare System
Hollywood, Florida, 33021
Houman Khalili
William Beaumont Hospital
Royal Oak, Michigan, 48073
Amr Abbas
Mayo Clinic
Rochester, Minnesota, 55905
Mackram F Eleid, M.D.
St-Joseph's Health INC
Syracuse, New York, 13203
Ayman Iskander

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