Clinical trial NCT03520101: 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. The 'LYTEN' 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Aortic Valve Stenosis
Regurgitation, Aortic
Prosthesis Failure
Lead sponsor: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Sponsor class: OTHER
First posted: 2018-05-09
Enrollment: 102
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of prothesis-patient mismatch (PPM) (valve performance)
timeFrame: 30 days
measure: Residual transvalvular gradient
timeFrame: 30 days
Secondary outcomes:
measure: Transvalvular gradient.
timeFrame: 1-year
measure: Valve performance : Moderate or severe PPM moderate-severe AR at 30 days and 1 year.
timeFrame: 30 days and 1 year
measure: Combined endpoints: Moderate-severe AR or severe PPM at 1-year follow-up.
timeFrame: 1 year
measure: Clinical safety endpoints
timeFrame: 30 days and 1 year
measure: Exercise capacity
timeFrame: 30 days and 1 year
measure: Changes in LV hypertrophy
timeFrame: 30 days and 1 year
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: IUCPQ
Study officials:
affiliation: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
name: Josep Rodés-Cabau, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rodes-Cabau J, Abbas AE, Serra V, Vilalta V, Nombela-Franco L, Regueiro A, Al-Azizi KM, Iskander A, Conradi L, Forcillo J, Lilly S, Calabuig A, Fernandez-Nofrerias E, Mohammadi S, Panagides V, Pelletier-Beaumont E, Pibarot P. Balloon- vs Self-Expanding Valve Systems for Failed Small Surgical Aortic Valve Bioprostheses. J Am Coll Cardiol. 2022 Aug 16;80(7):681-693. doi: 10.1016/j.jacc.2022.05.005. Epub 2022 May 18.