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Valve Optimization for ViV TAVR

This study is looking at the best way to optimize a new heart valve after a procedure called valve-in-valve Transcatheter Aortic Valve Replacement (ViV TAVR). ViV TAVR is when a new valve is placed inside an old, failing surgical heart valve. Researchers are comparing two methods to guide this optimization: using Doppler-echocardiography (a type of ultrasound) or using invasive hemodynamic measurements (measurements taken directly inside the heart with a catheter). You may be able to join if you have a failing surgical aortic valve (Aortic Valve Stenosis or Aortic Valve Regurgitation) that is approved for a ViV TAVR with the SAPIEN 3 Ultra valve. The study aims to see how these different optimization methods affect your quality of life and any complications during the procedure. The study plans to enroll 310 participants.

Study design
This is a prospective, multicenter, randomized, single-blinded study. It will include 310 participants.
What's involved
You would undergo a ViV TAVR procedure with the SAPIEN 3 Ultra valve, with further interventions based on either Doppler-echocardiography or invasive hemodynamic measurements.
Compensation
Not stated in the trial record.
Follow-up
Your quality of life will be measured at 12 months after the procedure, and periprocedural complications will be measured around the time of the procedure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05459233

Valve Hemodynamic Optimization Based on Doppler-Echocardiography vs Catheterization Measurements Following ViV TAVR

Recruiting
NAAges 18+InterventionalTreatment
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
~310 participants
Updated 2026-03-24 on ClinicalTrials.gov
What's tested:Doppler-echocardiographyInvasive hemodynamic measurements

At a glance

Recruiting sites
5 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Changes in Quality of life (Efficacy)
Measured over 12 months follow-up
+1 more outcome measured

Conditions

Aortic Valve Stenosis
Aortic Valve Regurgitation
Prosthesis Failure

Explore related trials

Aortic Valve InsufficiencyAortic Valve StenosisProsthesis Failure

Where it's being run

7 sites across 7 states
California1
Florida1
Michigan1
Minnesota1
New York1
Ohio1
Quebec1

Study leadership

  • Josep Rodés-Cabau, MD · PRINCIPAL_INVESTIGATOR · Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Who to contact

Josep Rodés-Cabau, MD
[email protected]
418-656-8711
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

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
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

What this trial measures

  • Changes in Quality of life (Efficacy)12 months follow-up

    Change in quality of life as evaluated by the Kansas City Cardiomyopathy Questionnaire (KCCQ). All score are represented on a 0-to-100-point scale (lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life).The KCCQ is a 7 domains questionnaire; symptom frequency, symptom burden, symptom stability, physical limitations, social limitations, quality of life and self-efficacy.

  • Periprocedural complications (Safety)Periprocedural

    Periprocedural complications including in-hospital mortality, stroke, annular rupture, coronary obstruction, new-onset left bundle branch block, need for permanent pacemaker implantation and conversion to open heart surgery.