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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

NCT ID: NCT03520101

Last Updated: 2023-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-10

Study Completion Date

2024-05-31

Brief Summary

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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

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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.

Conditions

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Aortic Valve Stenosis Regurgitation, Aortic Prosthesis Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SAPIEN

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

Group Type OTHER

TAVI_ViV procedure with Edwards valve

Intervention Type 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.

COREVALVE

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.

Group Type OTHER

TAVI_ViV procedure with CoreValve system

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Josep Rodes-Cabau

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Josep Rodés-Cabau, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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IUCPQ

Québec, , Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 37902146 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35597385 (View on PubMed)

Other Identifiers

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LYTEN

Identifier Type: -

Identifier Source: org_study_id