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

Recruiting now · Not applicable

Conditions studied: Aortic Valve Stenosis, Aortic Valve Regurgitation, Prosthesis Failure

In brief

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,

Key facts

Study ID

NCT05459233

Run by

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

People needed

310

Starts

2023-01-11

Expected to finish

2029-09-01

Last updated by the study team

2026-03-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States (enrolling)
• South Broward Hospital Disctrict D/B/A Memorial Healthcare System — Hollywood, Florida, United States (enrolling)
• William Beaumont Hospital — Royal Oak, Michigan, United States (enrolling)
• The Christ Hospital Health Network — Cincinnati, Ohio, United States (enrolling)
• IUCPQ — Québec, Quebec, Canada (enrolling)
• University of California — San Francisco, California, United States
• St-Joseph's Health INC — Syracuse, New York, United States

Full record on ClinicalTrials.gov

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