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

C

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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