RecruitingNot Applicable

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

United States310 participantsStarted 2023-01-11

Plain-language 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,

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Changes in Quality of life (Efficacy)

Timeframe: 12 months follow-up

Periprocedural complications (Safety)

Timeframe: Periprocedural

Trial details

NCT IDNCT05459233

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

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-09-01

Contact for this trial

Josep Rodés-Cabau, MD

418-656-8711 josep.rodes@criucpq.ulaval.ca