Aortic Valve Stenosis Clinical Trial
Official title:
Comparison of the Balloon-Expandable Edwards Valve and Self-Expandable CoreValve Evolut R or Evolut PRO System for the Treatment of Small, Severely Dysfunctional Surgical Aortic Bioprotheses: A Pilot Prospective Randomized Trial. The 'LYTEN' Trial
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.
Status | Active, not recruiting |
Enrollment | 102 |
Est. completion date | May 31, 2024 |
Est. primary completion date | February 22, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | IUCPQ | Quebec |
Lead Sponsor | Collaborator |
---|---|
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | 30 days | |
Primary | Residual transvalvular gradient | Residual (maximal and mean) transvalvular gradient. | 30 days | |
Secondary | Transvalvular gradient. | Maximal and mean transvalvular gradient | 1-year | |
Secondary | Valve performance : Moderate or severe PPM moderate-severe AR at 30 days and 1 year. | Moderate or severe PPM; moderate-severe AR. | 30 days and 1 year | |
Secondary | Combined endpoints: Moderate-severe AR or severe PPM at 1-year follow-up. | Moderate-severe AR or severe PPM. | 1 year | |
Secondary | Clinical safety endpoints | individually and combined: death, stroke, major or life threatening bleeding, pacemaker implantation, myocardial infarction. | 30 days and 1 year | |
Secondary | Exercise capacity | Exercise capacity as evaluated by the six-minute walk test | 30 days and 1 year | |
Secondary | Changes in LV hypertrophy | Changes in LV hypertrophy | 30 days and 1 year |
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