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

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

Status: Enrolling

Conditions: Aortic Valve Stenosis; Aortic Valve Regurgitation; Prosthesis Failure

Treatments: Procedure: Doppler-echocardiography; Procedure: Invasive hemodynamic measurements

Study type: Interventional

Funder types: Other

Identifiers

NCT05459233

ECHOCATH

Details and patient eligibility

About

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,

Full 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.

Enrollment: 310 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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310 participants in 2 patient groups

Doppler-echocardiography

Other group

Description:

Following valve implantation, further intervention will be based on Doppler-echocardiographic measurements.

Treatment:

Procedure: Doppler-echocardiography

Invasive hemodynamic measurements

Other group

Description:

Following valve implantation, further interventions will be based on invasive hemodynamic measurements (with simultaneous aortic and ventricular pressure recording).

Treatment:

Procedure: Invasive hemodynamic measurements