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

NAActive, not recruitingINTERVENTIONAL
Enrollment

102

Participants

Timeline

Start Date

May 10, 2017

Primary Completion Date

February 22, 2022

Study Completion Date

May 31, 2024

Conditions
Aortic Valve StenosisRegurgitation, AorticProsthesis Failure
Interventions
PROCEDURE

TAVI_ViV procedure with Edwards valve

The TAVR procedure will be performed following the standards of each participating center. No restriction or specific recommendation will be given regarding the approach, general vs. local anesthesia, imaging guidance during the TAVI procedure, and post-procedural TAVI management. The decision for selecting either a 20 or 23mm Edwards valve will be based on 3D CT measurements of the mean inner diameter of the surgical aortic bioprosthesis. A 23mm Sapien 3 valve will be recommended if the inner diameter is \>18 mm, and a 20mm valve will be selected if the mean inner diameter is ≤18 mm.

PROCEDURE

TAVI_ViV procedure with CoreValve system

The TAVR procedure will be performed following the standards of each participating center. No restriction or specific recommendation will be given regarding the approach, general vs. local anesthesia, imaging guidance during the TAVI procedure, and post-procedural TAVI management. A 23mm valve will be recommended in all patients randomized to the self-expanding CoreValve Evolut R system.

Trial Locations (1)

G1V 4G5

IUCPQ, Québec

All Listed Sponsors
lead

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

OTHER

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 | Biotech Hunter | Biotech Hunter