About this trial
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 criteria
Qualifiers
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
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Doppler-echocardiography
- Invasive hemodynamic measurements
Treatment groups
Locations
7Sponsors and collaborators
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Lead sponsor