Aortic Valve Stenosis, Prosthesis Failure, Regurgitation, Aortic
Conditions
Brief summary
The treatment with transcatheter aortic valve implantation (TAVI) of patients with small (≤23mm) surgical bioprostheses remains a challenge due to the increased transvalvular residual gradients and high rates of severe prosthesis-patient mismatch (PPM) following the procedure.
Detailed description
This is a prospective, multicenter, randomized open-label trial including patients with surgical aortic bioprosthetic dysfunction in the presence of a small (≤23mm; inner diameter ≤21 mm) stented surgical valve. Following the Heart Team'S decision to proceed with a TAVI-ViV procedure, patients will be randomized to either receive an Edwards (SAPIEN XT or SAPIEN 3) valve or a CoreValve Evolut R or Evolut PRO system. New iterations of these valve models may also be included.
Interventions
PROCEDURETAVI_ViV procedure with Edwards valve
The TAVR procedure will be performed following the standards of each participating center. No restriction or specific recommendation will be given regarding the approach, general vs. local anesthesia, imaging guidance during the TAVI procedure, and post-procedural TAVI management. The decision for selecting either a 20 or 23mm Edwards valve will be based on 3D CT measurements of the mean inner diameter of the surgical aortic bioprosthesis. A 23mm Sapien 3 valve will be recommended if the inner diameter is \>18 mm, and a 20mm valve will be selected if the mean inner diameter is ≤18 mm.
PROCEDURETAVI_ViV procedure with CoreValve system
The TAVR procedure will be performed following the standards of each participating center. No restriction or specific recommendation will be given regarding the approach, general vs. local anesthesia, imaging guidance during the TAVI procedure, and post-procedural TAVI management. A 23mm valve will be recommended in all patients randomized to the self-expanding CoreValve Evolut R system.
Sponsors
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, multicenter, randomized trial including patients with surgical aortic bioprosthetic dysfunction in the presence of a small stented surgical valve. Patients will be randomized to either receive an Edwards (SAPIEN XT or SAPIEN 3) valve or a Core Valve Evolut R or Evolut PRO system.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients with surgical aortic bioprosthetic dysfunction defined as severe aortic stenosis and/or regurgitation approved for a ViV procedure by the Heart Team * Stented surgical valves. * Small (≤23mm) surgical valve
Exclusion criteria
\- Stentless or sutureless surgical valves
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of prothesis-patient mismatch (PPM) (valve performance) | 30 days | Severe prothesis-patient mismatch (PPM) (defined as an index aortic valve area ≤0.65 cm2/m2) and/or moderate-severe aortic regurgitation (AR) (VARC-2 definition). |
| Residual transvalvular gradient | 30 days | Residual (maximal and mean) transvalvular gradient. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Transvalvular gradient. | 1-year and yearly thereafter up to 10-year follow-up | Maximal and mean transvalvular gradient |
| Valve performance : Moderate or severe PPM moderate-severe AR at 30 days and 1 year. | 30 days, 1 year and yearly thereafter up to 10-year follow-up | Moderate or severe PPM; moderate-severe AR. |
| Combined endpoints: Moderate-severe AR or severe PPM at 1-year follow-up. | 1 year and yearly thereafter up to 10-year follow-up | Moderate-severe AR or severe PPM. |
| Clinical safety endpoints | 30 days, 1 year and yearly thereafter up to 10-year follow-up | individually and combined: death, stroke, major or life threatening bleeding, pacemaker implantation, myocardial infarction. |
| Exercise capacity | 30 days, 1 year and yearly thereafter up to 10-year follow-up | Exercise capacity as evaluated by the six-minute walk test |
| Changes in LV hypertrophy | 30 days , 1 year and yearly thereafter up to 10-year follow-up | Changes in LV hypertrophy |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORJosep Rodés-Cabau, MD
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Outcome results
None listed