Valve Hemodynamic Optimization Based on Doppler-Echocardiography vs Catheterization Measurements Following ViV TAVR
- Conditions
- Prosthesis FailureAortic Valve StenosisAortic Valve Regurgitation
- Interventions
- Procedure: Doppler-echocardiographyProcedure: Invasive hemodynamic measurements
- Registration Number
- NCT05459233
- Lead Sponsor
- Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
- Brief Summary
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,
- Detailed Description
This is a prospective, multicenter, randomized, single-blinded design trial including patients with surgical aortic bioprosthetic dysfunction in the presence of a stented surgical bioprosthesis with a labeled size ≤25 mm. Following the Heart Team's decision to proceed with a ViV-TAVR procedure with the SAPIEN 3 ULTRA valve (or its subsequent iterations), patients will be randomized to valve hemodynamic optimization according to Doppler-echocardiography versus cardiac catheterization parameters.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 310
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Doppler-echocardiography Doppler-echocardiography Following valve implantation, further intervention will be based on Doppler-echocardiographic measurements. Invasive hemodynamic measurements Invasive hemodynamic measurements Following valve implantation, further interventions will be based on invasive hemodynamic measurements (with simultaneous aortic and ventricular pressure recording).
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Clinical safety endpoints 1 and 12 months follow-up and yearly up to 5 years Individually and combined: death, stroke, major of lifethreatening bleeding, pacemaker implantation, myocardial infarction
re-hospitalization 1 and 12 months follow-up and yearly up to 5 years Need for re-hospitalization
Heart failure 1 and 12 months follow-up and yearly up to 5 years Evaluated by the New York Heart Association (NYHA) Functional Classification
Changes in Quality of life after 1-year follow-up (yearly up to 5 years) 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.
Changes in Left ventricle mass 1-month and 1-year follow-up Changes in LV mass
Residual transvalvular gradient 1 month and 12 months follow-up Residual (maximal and mean) transvalvular gradient
Combined enpoint: Moderate or severe prothesis-patient mismatch and/or moderate or severe aortic regurgitation (valve performance) 1 month and 12 months follow-up Moderate or severe prothesis-patient mismatch (defines as an index aortic valve area 0.85-0.66 cm2/m2 (moderate), ≤0.65 cm2/m2 (severe) for patient with BMI ˂30km/m2 and 0.70-0.56 cm2/m2 (moderate), ≤0.55 cm2/m2 (severe) for patient with BMI ≥30km/m2 and/or moderate-severe aortic regurgitation (AR) (VARC-3 definition).
Exercise capacity 1 month and 12 months follow-up Exercise capacity as evaluated by the six-minute wlak test.
wear and tear deterioration (Structural valve degeneration) 1 and 12 months follow-up and yearly up to 5 years wear and tear evaluated by echocardiography imaging
flail leaflet (Structural valve degeneration) 1 and 12 months follow-up and yearly up to 5 years flail leaflet evaluated by echocardiography imaging
leaflet fibrosis and/or calcification (Structural valve degeneration) 1 and 12 months follow-up and yearly up to 5 years leaflet fibrosis and/or calcification evaluated by echocardiography imaging
Leaflet disruption (Structural valve degeneration) 1 and 12 months follow-up and yearly up to 5 years leaflet disruption evaluated by echocardiography imaging
strut fracture or deformation (Structural valve degeneration) 1 and 12 months follow-up and yearly up to 5 years strut fracture or deformation evaluated by echocardiography imaging
Valve re-intervention 1 and 12 months follow-up and yearly up to 5 years Need for valve re-intervention
Trial Locations
- Locations (7)
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
St-Joseph's Health INC
🇺🇸Syracuse, New York, United States
University of California
🇺🇸San Francisco, California, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
South Broward Hospital Disctrict D/B/A Memorial Healthcare System
🇺🇸Hollywood, Florida, United States
IUCPQ
🇨🇦Quebec, Canada
The Christ Hospital Health Network
🇺🇸Cincinnati, Ohio, United States