An interventional study of Doppler-echocardiography and Invasive hemodynamic measurements in Aortic Valve Stenosis, Aortic Valve Regurgitation and Prosthesis Failure, sponsored by Institut universitaire de cardiologie et de pneumologie de Québec, University Laval. Recruiting at 7 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-24.
Sponsored by Institut universitaire de cardiologie et de pneumologie de Québec, University Laval · Not applicable, Interventional, and Treatment
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,
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.
1,025 studies on the registry are indexed under Aortic Valve Stenosis; 293 are open to participants now.
This study's planned enrollment of 310 is above the median of 126 across 554 interventional studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →Institut universitaire de cardiologie et de pneumologie de Québec, University Laval is the lead sponsor of 15 studies on the registry; 9 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Following valve implantation, further intervention will be based on Doppler-echocardiographic measurements.
Procedure: Doppler-echocardiography
Following valve implantation, further interventions will be based on invasive hemodynamic measurements (with simultaneous aortic and ventricular pressure recording).
Procedure: Invasive hemodynamic measurements
The TAVR (valve-in-valve) procedure will be performed with the SAPIEN 3 Ultra valve, with valve sizing according to current manufacturer recommendations. Following valve implantation, further intervention will be based on Doppler-echocardiographic measurements. Balloon post-dilation with a non-compliant balloon will be performed in the presence of a residual mean gradient ≥20 mmHg as assessed by Doppler-echocardiography.
The TAVR (valve-in-valve) procedure will be performed with the SAPIEN 3 Ultra valve, with valve sizing according to current manufacturer recommendations. Following valve implantation, further interventions will be based on invasive hemodynamic measurements (with simultaneous aortic and ventricular pressure recording). Balloon post-dilation will be performed with a non-compliant balloon in the presence of a mean residual gradient ≥20 mmHg as assessed by hemodynamic measurements.
Changes in Quality of life (Efficacy)
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.
Time frame: 12 months follow-up
Periprocedural complications (Safety)
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.
Time frame: Periprocedural
Residual transvalvular gradient
Residual (maximal and mean) transvalvular gradient
Time frame: 1 month and 12 months follow-up
Combined enpoint: Moderate or severe prothesis-patient mismatch and/or moderate or severe aortic regurgitation (valve performance)
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).
Time frame: 1 month and 12 months follow-up
Heart failure
Evaluated by the New York Heart Association (NYHA) Functional Classification
Time frame: 1 and 12 months follow-up and yearly up to 5 years
Exercise capacity
Exercise capacity as evaluated by the six-minute wlak test.
Time frame: 1 month and 12 months follow-up
Changes in Quality of life
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.
Time frame: after 1-year follow-up (yearly up to 5 years)
Clinical safety endpoints
Individually and combined: death, stroke, major of lifethreatening bleeding, pacemaker implantation, myocardial infarction
Time frame: 1 and 12 months follow-up and yearly up to 5 years
re-hospitalization
Need for re-hospitalization
Time frame: 1 and 12 months follow-up and yearly up to 5 years
wear and tear deterioration (Structural valve degeneration)
wear and tear evaluated by echocardiography imaging
Time frame: 1 and 12 months follow-up and yearly up to 5 years
Leaflet disruption (Structural valve degeneration)
leaflet disruption evaluated by echocardiography imaging
Time frame: 1 and 12 months follow-up and yearly up to 5 years
flail leaflet (Structural valve degeneration)
flail leaflet evaluated by echocardiography imaging
Time frame: 1 and 12 months follow-up and yearly up to 5 years
leaflet fibrosis and/or calcification (Structural valve degeneration)
leaflet fibrosis and/or calcification evaluated by echocardiography imaging
Time frame: 1 and 12 months follow-up and yearly up to 5 years
strut fracture or deformation (Structural valve degeneration)
strut fracture or deformation evaluated by echocardiography imaging
Time frame: 1 and 12 months follow-up and yearly up to 5 years
Valve re-intervention
Need for valve re-intervention
Time frame: 1 and 12 months follow-up and yearly up to 5 years
Changes in Left ventricle mass
Changes in LV mass
Time frame: 1-month and 1-year follow-up
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Institut universitaire de cardiologie et de pneumologie de Québec, University Laval