Aortic Valve Stenosis, Aortic Valve Regurgitation, Prosthesis Failure
Conditions
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.
Interventions
PROCEDUREDoppler-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 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.
PROCEDUREInvasive 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 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.
Sponsors
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Single-blinded trial
Intervention model description
Patients will be randomized in a 1:1 fashion to valve hemodynamic optimization according to Doppler-echocardiography versus cardiac catheterization parameters.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| Heart failure | 1 and 12 months follow-up and yearly up to 5 years | Evaluated by the New York Heart Association (NYHA) Functional Classification |
| Exercise capacity | 1 month and 12 months follow-up | Exercise capacity as evaluated by the six-minute wlak test. |
| 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. |
| 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 |
| 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 |
| Leaflet disruption (Structural valve degeneration) | 1 and 12 months follow-up and yearly up to 5 years | leaflet disruption 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 |
| 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 |
| Changes in Left ventricle mass | 1-month and 1-year follow-up | Changes in LV mass |
Countries
Canada, United States
Contacts
CONTACTJosep Rodés-Cabau, MD
CONTACTEmilie Pelletier Beaumont, MSc
PRINCIPAL_INVESTIGATORJosep Rodés-Cabau, MD
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Outcome results
None listed