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.
Key facts
- Who runs it
- Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
- Where
- Cincinnati, Hollywood, Rochester, Royal Oak, San Francisco, and Syracuse, United StatesSee the 6 sitesAlso in 1 other country, 1 site
- Trial code
- Registry title
- Valve Hemodynamic Optimization Based on Doppler-Echocardiography vs Catheterization Measurements Following ViV TAVR
- Status
- Recruiting
- People taking part
- 310 people, planned
- Started
- 11 Jan 2023
- Expected to end
- 1 Sept 2029
- Type of study
- Interventional, 2 groups
- Treatments tested
- Doppler-echocardiography
- Invasive hemodynamic measurements
- Record updated
- 24 March 2026
Who can take part
AI summary
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
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in United States
Also in 1 other country, 1 site
- The Christ Hospital Health NetworkCincinnati, United StatesContact: Santiago Garcia, M.D.Taking people
- South Broward Hospital Disctrict D/B/A Memorial Healthcare SystemHollywood, United StatesContact: Houman KhaliliTaking people
- Mayo ClinicRochester, United StatesContact: Mackram F Eleid, M.D.Taking people
- William Beaumont HospitalRoyal Oak, United StatesContact: Amr AbbasTaking people
- University of CaliforniaSan Francisco, United StatesContact: Sammy ElmariahNot yet recruiting
- St-Joseph's Health INCSyracuse, United StatesContact: Ayman IskanderNot yet recruiting
About the trial
What the trial wants to find out
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,
The 2 groups in the trial
- Doppler-echocardiographyOther group
Following valve implantation, further intervention will be based on Doppler-echocardiographic measurements.
- Invasive hemodynamic measurementsOther group
Following valve implantation, further interventions will be based on invasive hemodynamic measurements (with simultaneous aortic and ventricular pressure recording).
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 doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Valve Hemodynamic Optimization Based on Doppler-Echocardiography Versus Catheterization Measurements Following Valve-in-Valve TAVR: A Prospective Randomized Trial
- Plain-language title
- Comparing two ways to measure heart valve performance after valve-in-valve replacementGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 24 March 2026