Brief 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. 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
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.
Study Type
Interventional
Primary Outcome
Rate of prothesis-patient mismatch (PPM) (valve performance)
Secondary Outcome
Transvalvular gradient.
Condition
Aortic Valve Stenosis
Intervention
TAVI_ViV procedure with Edwards valve
Study Arms / Comparison Groups
SAPIEN
Description: Following the Heart Team's decision to proceed with a TAVI-ViV procedure, patients will received an Edwards (SAPIEN XT or SAPIEN 3) valve.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
102
Start Date
May 10, 2017
Completion Date
May 31, 2024
Primary Completion Date
February 22, 2022
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
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Josep Rodés-Cabau, MD, ,
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT03520101
Organization ID
LYTEN
Responsible Party
Principal Investigator
Study Sponsor
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Study Sponsor
Josep Rodés-Cabau, MD, Principal Investigator, Institut universitaire de cardiologie et de pneumologie de Québec
Verification Date
July 2022