Optimizing heart valve function using echocardiography or catheterization after valve replacement

Valve Hemodynamic Optimization Based on Doppler-Echocardiography Versus Catheterization Measurements Following Valve-in-Valve TAVR: A Prospective Randomized Trial

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

• Phase: NA
• Study type: Interventional
• Enrollment: 310 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval (other)
• Locations: 7 sites (San Francisco, California and 6 other locations)
• Trial ID: NCT05459233 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

San Francisco, California and 6 other locations

• University of California — San Francisco, California, United States (NOT_YET_RECRUITING)
• 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)
• St-Joseph's Health INC — Syracuse, New York, United States (NOT_YET_RECRUITING)
• The Christ Hospital Health Network — Cincinnati, Ohio, United States (RECRUITING)
• IUCPQ — Québec, Quebec, Canada (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

Conditions: Aortic Valve Stenosis, Aortic Valve Regurgitation, Prosthesis Failure