RecruitingNot ApplicableNCT05459233

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

Sponsor

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

Enrollment

310 participants

Start Date

Jan 11, 2023

Study Type

INTERVENTIONAL

Conditions

Aortic Valve Stenosis Aortic Valve Regurgitation Prosthesis Failure

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

Min Age: 18 Years

Inclusion Criteria3

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 Criteria5

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

Interventions

PROCEDUREDoppler-echocardiography

The TAVR (valve-in-valve) procedure will be performed with the SAPIEN 3 Ultra valve, with valve sizing according to current manufacturer recommendations. Following valve implantation, further intervention will be based on Doppler-echocardiographic measurements. Balloon post-dilation with a non-compliant balloon will be performed in the presence of a residual mean gradient ≥20 mmHg as assessed by Doppler-echocardiography.

PROCEDUREInvasive hemodynamic measurements

The TAVR (valve-in-valve) procedure will be performed with the SAPIEN 3 Ultra valve, with valve sizing according to current manufacturer recommendations. Following valve implantation, further interventions will be based on invasive hemodynamic measurements (with simultaneous aortic and ventricular pressure recording). Balloon post-dilation will be performed with a non-compliant balloon in the presence of a mean residual gradient ≥20 mmHg as assessed by hemodynamic measurements.