310
Participants
Start Date
January 11, 2023
Primary Completion Date
September 1, 2025
Study Completion Date
September 1, 2029
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.
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.
NOT_YET_RECRUITING
St-Joseph's Health INC, Syracuse
RECRUITING
South Broward Hospital Disctrict D/B/A Memorial Healthcare System, Hollywood
RECRUITING
The Christ Hospital Health Network, Cincinnati
RECRUITING
William Beaumont Hospital, Royal Oak
RECRUITING
Mayo Clinic, Rochester
NOT_YET_RECRUITING
University of California, San Francisco
RECRUITING
IUCPQ, Québec
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
OTHER