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

Valve Hemodynamic Optimization Based on Doppler-Echocardiography Versus Catheterization Measurements Following Valve-in-Valve TAVR: A Prospective Randomized Trial

Who can join

Ages 18 and older · All sexes

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

About the study

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,

What is being tested

• Doppler-echocardiography (procedure)
• Invasive hemodynamic measurements (procedure)

Sponsor: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval · Participants: 310 · Started: Jan 11, 2023

Contact the study team

• Josep Rodés-Cabau, MD · Phone: 418-656-8711
• Emilie Pelletier Beaumont, MSc · Phone: 418-656-8711

Official record on ClinicalTrials.gov — NCT05459233

Locations in the U.S.

Conditions

• Aortic Valve Stenosis
• Aortic Valve Insufficiency

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.