Optimizing heart valve function using echocardiography or catheterization after valve replacement
Official title: Valve Hemodynamic Optimization Based on Doppler-Echocardiography Versus Catheterization Measurements Following Valve-in-Valve TAVR: A Prospective Randomized Trial
Run by Institut universitaire de cardiologie et de pneumologie de Québec, University Laval · NCT05459233 · Data updated 2026-11-12
This study is testing whether using ultrasound or a catheter to check heart valve function after a replacement helps patients with aortic valve problems feel better and have better outcomes.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 310 (estimated) |
| Sponsor | Institut universitaire de cardiologie et de pneumologie de Québec, University Laval Academic / other |
| Locations | 7 sites (San Francisco, California and 6 other locations) |
| Status | Recruiting |
| Started | January 11, 2023 |
| Main results expected | September 1, 2027 |
| Study ends | September 1, 2029 |
| Registry record updated | March 24, 2026 |
| Trial ID | NCT05459233 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients with severe aortic stenosis and/or regurgitation who are approved for a valve-in-valve procedure with a surgical stented bioprosthetic valve of size ≤25 mm.
✕Probably not a fit
Patients with stentless or sutureless surgical valves, certain bioprostheses, or those at high risk for coronary obstruction may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to compare the effectiveness of valve hemodynamic optimization based on Doppler-echocardiography versus cardiac catheterization measurements in patients undergoing valve-in-valve transcatheter aortic valve replacement (ViV-TAVR). It is a prospective, multicenter, randomized, single-blinded trial that includes patients with surgical aortic bioprosthetic dysfunction. Participants will be randomized to receive either echocardiographic or catheterization-based optimization following the implantation of the SAPIEN 3 ULTRA valve. The study seeks to address discrepancies in valve performance evaluation methods and their impact on procedural outcomes.
Why it matters
Potential benefit: If successful, this study could lead to more accurate assessments of valve performance, potentially improving patient outcomes after ViV-TAVR procedures.
How similar studies have gone: Previous studies have indicated discrepancies between echocardiographic and catheterization measurements, suggesting that this approach could provide valuable insights, although the specific methodology of this trial may be novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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's running
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South Broward Hospital Disctrict D/B/A Memorial Healthcare System
Hollywood, Florida, United States Recruiting -
William Beaumont Hospital
Royal Oak, Michigan, United States Recruiting -
Mayo Clinic
Rochester, Minnesota, United States Recruiting -
The Christ Hospital Health Network
Cincinnati, Ohio, United States Recruiting -
Iucpq
Québec, Quebec, Canada Recruiting -
University of California
San Francisco, California, United States Not yet recruiting
Show 1 more location
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St-Joseph's Health INC
Syracuse, New York, United States Not yet recruiting
Study contacts
- Principal investigator: Josep Rodés-Cabau, MD — Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
- Study coordinator: Josep Rodés-Cabau, MD
- Email: josep.rodes@criucpq.ulaval.ca
- Phone: 418-656-8711
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Tracking progression and consequences of heart valve disease
This project will follow adults with moderate or worse valve disease to see if clinical tests and imaging can predict when their condition will get worse.
-
A quick 10-minute heart scan for cardiac diseases
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-
Transcatheter Aortic Valve Replacement Registry for Outcomes and Quality Monitoring
This registry collects information from hospitals about patients undergoing TAVR to see how care and outcomes compare to guidelines and nationwide data.
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Vericiguat to slow calcific aortic valve narrowing
This trial tests whether vericiguat can slow the progression of mild-to-moderate calcific aortic valve stenosis compared with placebo.
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CHATEAU Registry: Real-world outcomes after TAVR
This registry collects real-world data from adults who had TAVR between 2021 and 2025 to see how they do over time and how valve performance holds up.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.