Valve Hemodynamic Optimization Based on Doppler-Echocardiography vs Catheterization Measurements Following ViV TAVR
Recruiting · NCT05459233 · Interventional (participants receive a specific treatment) · Lead sponsor: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
View the official record on ClinicalTrials.gov →Interventions studied
Doppler-echocardiographyInvasive hemodynamic measurements
What this trial is about
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,
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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
Where it is running
7 locations listed across 6 US states.
- University of California - San Francisco, California, United States
- South Broward Hospital Disctrict D/B/A Memorial Healthcare System - Hollywood, Florida, United States
- William Beaumont Hospital - Royal Oak, Michigan, United States
- Mayo Clinic - Rochester, Minnesota, United States
- St-Joseph's Health INC - Syracuse, New York, United States
- The Christ Hospital Health Network - Cincinnati, Ohio, United States
- IUCPQ - Québec, Quebec, Canada