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

NCT03520101 | Active Not Recruiting

• 1 other identifier: LYTEN
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Valve Stenosis; Regurgitation, Aortic; Prosthesis Failure

Outcome Measures

Primary Outcomes (2)

• Rate of prothesis-patient mismatch (PPM) (valve performance)

  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).

  30 days

• Residual transvalvular gradient

  Residual (maximal and mean) transvalvular gradient.

  30 days

Secondary Outcomes (6)

• Transvalvular gradient.

  1-year and yearly thereafter up to 10-year follow-up

• Valve performance : Moderate or severe PPM moderate-severe AR at 30 days and 1 year.

  30 days, 1 year and yearly thereafter up to 10-year follow-up

• Combined endpoints: Moderate-severe AR or severe PPM at 1-year follow-up.

  1 year and yearly thereafter up to 10-year follow-up

• Clinical safety endpoints

  30 days, 1 year and yearly thereafter up to 10-year follow-up

• Exercise capacity

  30 days, 1 year and yearly thereafter up to 10-year follow-up

Study Arms (2)

SAPIEN

OTHER

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

Procedure: TAVI_ViV procedure with Edwards valve

COREVALVE

OTHER

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.

Procedure: TAVI_ViV procedure with CoreValve system

Interventions

TAVI_ViV procedure with Edwards valve PROCEDURE

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.

SAPIEN

TAVI_ViV procedure with CoreValve system PROCEDURE

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.

COREVALVE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- Stentless or sutureless surgical valves

Sponsors & Collaborators

• Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec: lead

Study Sites (1)

IUCPQ

Québec, Quebec, G1V 4G5, Canada

Location

Related Publications (3)

• Cepas-Guillen P, Abbas AE, Serra V, Vilalta V, Nombela-Franco L, Regueiro A, Al-Azizi KM, Iskander A, Conradi L, Forcillo J, Lilly S, Calabuig A, Fernandez-Nofrerias E, Mohammadi S, Giuliani C, Pelletier-Beaumont E, Pibarot P, Rodes-Cabau J. Balloon- Versus Self-Expanding Transcatheter Valves for Failed Small Surgical Aortic Bioprostheses: 3-Year Results of the LYTEN Trial. Circ Cardiovasc Interv. 2026 Mar;19(3):e016255. doi: 10.1161/CIRCINTERVENTIONS.125.016255. Epub 2026 Feb 2.

  PMID: 41623058 DERIVED

• Nuche J, Abbas AE, Serra V, Vilalta V, Nombela-Franco L, Regueiro A, Al-Azizi KM, Iskander A, Conradi L, Forcillo J, Lilly S, Calabuig A, Fernandez-Nofrerias E, Mohammadi S, Giuliani C, Pelletier-Beaumont E, Pibarot P, Rodes-Cabau J. Balloon- vs Self-Expanding Transcatheter Valves for Failed Small Surgical Aortic Bioprostheses: 1-Year Results of the LYTEN Trial. JACC Cardiovasc Interv. 2023 Dec 25;16(24):2999-3012. doi: 10.1016/j.jcin.2023.10.028. Epub 2023 Oct 23.

  PMID: 37902146 DERIVED

• Rodes-Cabau J, Abbas AE, Serra V, Vilalta V, Nombela-Franco L, Regueiro A, Al-Azizi KM, Iskander A, Conradi L, Forcillo J, Lilly S, Calabuig A, Fernandez-Nofrerias E, Mohammadi S, Panagides V, Pelletier-Beaumont E, Pibarot P. Balloon- vs Self-Expanding Valve Systems for Failed Small Surgical Aortic Valve Bioprostheses. J Am Coll Cardiol. 2022 Aug 16;80(7):681-693. doi: 10.1016/j.jacc.2022.05.005. Epub 2022 May 18.

  PMID: 35597385 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis; Aortic Valve Insufficiency; Prosthesis Failure

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Josep Rodés-Cabau, MD

  Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Prospective, multicenter, randomized trial including patients with surgical aortic bioprosthetic dysfunction in the presence of a small stented surgical valve. Patients will be randomized to either receive an Edwards (SAPIEN XT or SAPIEN 3) valve or a Core Valve Evolut R or Evolut PRO system.

Study Record Dates

• First Submitted: May 8, 2017
• First Posted: May 9, 2018
• Study Start: May 10, 2017
• Primary Completion: February 22, 2022
• Study Completion (Estimated): May 31, 2030
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

CA (1)