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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut universitaire de cardiologie et de pneumologie de Québec, University Laval

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

310 Participants
are divided into 2 treatment groups