NCT05459233Recruiting
Valve Hemodynamic Optimization Based on Doppler-Echocardiography vs Catheterization Measurements Following ViV TAVR
Valve Hemodynamic Optimization Based on Doppler-Echocardiography Versus Catheterization Measurements Following Valve-in-Valve TAVR: A Prospective Randomized Trial
Source: ClinicalTrials.gov · Last updated 24 Mar 2026
Brief summary (registry, in English)
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,
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 310 (estimated)
- First submitted
- 4 Jul 2022
- Start date
- Jan 2023
- Primary completion date
- Sept 2027
- Lead sponsor
- Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
- NCT number
- NCT05459233
What you commit to
- Study type: Interventional
- Planned participants: 310
- From Jan 2023 to the primary completion date, Sept 2027
- 7 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Stentless or sutureless surgical valves
Other illness
- 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).
Other
- Trifecta bioprosthesis
- Hancock II bioprosthesis
- Impossibility to obtain written informed consent
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IUCPQ Coordinator of this site? Confirm its status | Québec | Canada | Recruiting |
| The Christ Hospital Health Network Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
| South Broward Hospital Disctrict D/B/A Memorial Healthcare System Coordinator of this site? Confirm its status | Hollywood | United States | Recruiting |
| Mayo Clinic Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
| William Beaumont Hospital Coordinator of this site? Confirm its status | Royal Oak | United States | Recruiting |
| University of California Coordinator of this site? Confirm its status | San Francisco | United States | Not yet recruiting |
| St-Joseph's Health INC Coordinator of this site? Confirm its status | Syracuse | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.