Comparing two ways to measure heart valve performance after valve-in-valve replacement
Compares ultrasound and catheter measurements to guide valve optimization in adults with valve problems.
Plain-language title generated from the registry record
Registry title: Valve Hemodynamic Optimization Based on Doppler-Echocardiography vs Catheterization Measurements Following ViV TAVR
Key facts
- Where
- Québec, CanadaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults whose surgical bioprosthetic aortic valve has failed and who are approved for a valve-in-valve procedure with the SAPIEN 3 Ultra valve.
- Age
- 18 years and older
- Sex
- All
- Disease stage
- Failed surgical bioprosthetic aortic valve, with severe aortic stenosis and/or regurgitation, approved by the Heart Team for a valve-in-valve procedure.
- Earlier treatment
- A surgical stented bioprosthetic aortic valve (label size ≤25 mm) already in place.
Main reasons for not taking part
- Stentless or sutureless surgical valves
- Trifecta bioprosthesis
- Hancock II bioprosthesis
- High risk of coronary obstruction (valve-to-coronary distance on CT <4 mm, or Heart Team judgement)
- Cannot give written informed consent
Read by machine on 12 November 2026.
Where in Canada
- IUCPQQuébec, CanadaContact: Josep Rodes-Cabau, MDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
- Trial code
- NCT05459233
- Record updated
- 24 March 2026
- Original description
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,Read full original descriptionShow less
Valve Hemodynamic Optimization Based on Doppler-Echocardiography Versus Catheterization Measurements Following Valve-in-Valve TAVR: A Prospective Randomized 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,
Inclusion: 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: Stentless or sutureless surgical valves; 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); Trifecta bioprosthesis; Hancock II bioprosthesis; Impossibility to obtain written informed consent.