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

Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Status: Active, not recruiting

Conditions: Aortic Valve Stenosis; Prosthesis Failure; Regurgitation, Aortic

Treatments: Procedure: TAVI_ViV procedure with CoreValve system; Procedure: TAVI_ViV procedure with Edwards valve

Study type: Interventional

Funder types: Other

Identifiers

NCT03520101

LYTEN

Details and patient eligibility

About

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.

Full 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.

Enrollment: 102 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 2 patient groups

SAPIEN

Other group

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.

Treatment:

Procedure: TAVI_ViV procedure with Edwards valve

COREVALVE

Other group

Description:

Following the Heart Team's decision to proceed with a TAVI-ViV procedure, patients will received the CoreValve Evolut R or Evolut PRO valve system.

Treatment:

Procedure: TAVI_ViV procedure with CoreValve system