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

NARecruitingINTERVENTIONAL
Enrollment

310

Participants

Timeline

Start Date

January 11, 2023

Primary Completion Date

September 1, 2025

Study Completion Date

September 1, 2029

Conditions
Aortic Valve StenosisAortic Valve RegurgitationProsthesis Failure
Interventions
PROCEDURE

Doppler-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.

PROCEDURE

Invasive 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.

Trial Locations (7)

13203

NOT_YET_RECRUITING

St-Joseph's Health INC, Syracuse

33021

RECRUITING

South Broward Hospital Disctrict D/B/A Memorial Healthcare System, Hollywood

45219

RECRUITING

The Christ Hospital Health Network, Cincinnati

48073

RECRUITING

William Beaumont Hospital, Royal Oak

55905

RECRUITING

Mayo Clinic, Rochester

94143

NOT_YET_RECRUITING

University of California, San Francisco

G1V 4G5

RECRUITING

IUCPQ, Québec

All Listed Sponsors
lead

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

OTHER