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

Aortic Valve Stenosis Clinical Trial

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

Clinical Trial 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,

Clinical Trial Description

This is a prospective, multicenter, randomized, single-blinded design trial including patients with surgical aortic bioprosthetic dysfunction in the presence of a stented surgical bioprosthesis with a labeled size ≤25 mm. Following the Heart Team's decision to proceed with a ViV-TAVR procedure with the SAPIEN 3 ULTRA valve (or its subsequent iterations), patients will be randomized to valve hemodynamic optimization according to Doppler-echocardiography versus cardiac catheterization parameters. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05459233
Study type Interventional
Source Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Contact Josep Rodés-Cabau, MD
Phone 418-656-8711
Email josep.rodes@criucpq.ulaval.ca
Status Recruiting
Phase N/A
Start date January 11, 2023
Completion date September 1, 2029
View Details
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