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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
102
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.
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.
IUCPQ
Québec, Canada
Rate of prothesis-patient mismatch (PPM) (valve performance)
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).
Time frame: 30 days
Residual transvalvular gradient
Residual (maximal and mean) transvalvular gradient.
Time frame: 30 days
Transvalvular gradient.
Maximal and mean transvalvular gradient
Time frame: 1-year
Valve performance : Moderate or severe PPM moderate-severe AR at 30 days and 1 year.
Moderate or severe PPM; moderate-severe AR.
Time frame: 30 days and 1 year
Combined endpoints: Moderate-severe AR or severe PPM at 1-year follow-up.
Moderate-severe AR or severe PPM.
Time frame: 1 year
Clinical safety endpoints
individually and combined: death, stroke, major or life threatening bleeding, pacemaker implantation, myocardial infarction.
Time frame: 30 days and 1 year
Exercise capacity
Exercise capacity as evaluated by the six-minute walk test
Time frame: 30 days and 1 year
Changes in LV hypertrophy
Changes in LV hypertrophy
Time frame: 30 days and 1 year
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