Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

Summary

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,

Official Title

Valve Hemodynamic Optimization Based on Doppler-Echocardiography Versus Catheterization Measurements Following Valve-in-Valve TAVR: A Prospective Randomized Trial

Details

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.

Keywords

Aortic Valve Stenosis, Aortic Valve Regurgitation, Prosthesis Failure, Aortic Valve Insufficiency, Doppler-echocardiography, Invasive hemodynamic measurements

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California not yet accepting patients
    San Francisco California 94143 United States
  • Mayo Clinic accepting new patients
    Rochester Minnesota 55905 United States
  • The Christ Hospital Health Network accepting new patients
    Cincinnati Ohio 45219 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
ID
NCT05459233
Study Type
Interventional
Participants
Expecting 310 study participants
Last Updated