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

Not Applicable

Active, not recruiting

• Conditions: Regurgitation, Aortic; Prosthesis Failure; Aortic Valve Stenosis
• Interventions: Procedure: TAVI_ViV procedure with CoreValve system; Procedure: TAVI_ViV procedure with Edwards valve

• Registration Number: NCT03520101
• Lead Sponsor: Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

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 Timeline

• Study First Submitted: 2017-05-08
• Study Start: 2017-05-10
• Study First Submitted QC: 2018-04-26
• Study First Posted: 2018-05-09
• Primary Completion: 2022-02-22
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-19
• Last Update Posted: 2023-12-20
• Study Completion: 2024-05-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 102

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
COREVALVE	TAVI_ViV procedure with CoreValve system	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.
SAPIEN	TAVI_ViV procedure with Edwards valve	Following the Heart Team's decision to proceed with a TAVI-ViV procedure, patients will received an Edwards (SAPIEN XT or SAPIEN 3) valve.

Primary Outcome Measures

Name	Time	Method
Residual transvalvular gradient	30 days	Residual (maximal and mean) transvalvular gradient.
Rate of prothesis-patient mismatch (PPM) (valve performance)	30 days	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).

Secondary Outcome Measures

Name	Time	Method
Changes in LV hypertrophy	30 days and 1 year	Changes in LV hypertrophy
Transvalvular gradient.	1-year	Maximal and mean transvalvular gradient
Valve performance : Moderate or severe PPM moderate-severe AR at 30 days and 1 year.	30 days and 1 year	Moderate or severe PPM; moderate-severe AR.
Clinical safety endpoints	30 days and 1 year	individually and combined: death, stroke, major or life threatening bleeding, pacemaker implantation, myocardial infarction.
Exercise capacity	30 days and 1 year	Exercise capacity as evaluated by the six-minute walk test
Combined endpoints: Moderate-severe AR or severe PPM at 1-year follow-up.	1 year	Moderate-severe AR or severe PPM.

Trial Locations

Locations (1)

IUCPQ; 🇨🇦 Quebec, Canada