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NCT Number: 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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Aortic Valve Insufficiency Cardiovascular Diseases Heart Diseases Heart Valve Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Prosthesis Failure Regurgitation, Aortic Ventricular Outflow Obstruction

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IUCPQ

Québec, Quebec, G1V 4G5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Rate of prothesis-patient mismatch (PPM) (valve performance)

    Time frame: 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).

  2. Residual transvalvular gradient

    Time frame: 30 days

    Residual (maximal and mean) transvalvular gradient.

Secondary outcomes

  1. Transvalvular gradient.

    Time frame: 1-year and yearly thereafter up to 10-year follow-up

    Maximal and mean transvalvular gradient

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

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

    Moderate or severe PPM; moderate-severe AR.

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

    Time frame: 1 year and yearly thereafter up to 10-year follow-up

    Moderate-severe AR or severe PPM.

  4. Clinical safety endpoints

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

    individually and combined: death, stroke, major or life threatening bleeding, pacemaker implantation, myocardial infarction.

  5. Exercise capacity

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

    Exercise capacity as evaluated by the six-minute walk test

  6. Changes in LV hypertrophy

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

    Changes in LV hypertrophy

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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: A Pilot Prospective Randomized Trial. The 'LYTEN' Trial

Important dates

Study start
2017
Primary completion
2022
Study completion
2030
First posted
May 9, 2018
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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