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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

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ClinicalTrials.gov Identifier: NCT03520101
Recruitment Status : Active, not recruiting
First Posted : May 9, 2018
Last Update Posted : February 2, 2022
Sponsor:
Information provided by (Responsible Party):
Josep Rodes-Cabau, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Study Description
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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.

Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Regurgitation, Aortic Prosthesis Failure Procedure: TAVI_ViV procedure with Edwards valve Procedure: TAVI_ViV procedure with CoreValve system Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : May 10, 2017
Estimated Primary Completion Date : February 22, 2022
Estimated Study Completion Date : May 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 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.
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Transvalvular gradient. [ Time Frame: 1-year ]
    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 and 1 year ]
    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 ]
    Moderate-severe AR or severe PPM.

  4. Clinical safety endpoints [ Time Frame: 30 days and 1 year ]
    individually and combined: death, stroke, major or life threatening bleeding, pacemaker implantation, myocardial infarction.

  5. Exercise capacity [ Time Frame: 30 days and 1 year ]
    Exercise capacity as evaluated by the six-minute walk test

  6. Changes in LV hypertrophy [ Time Frame: 30 days and 1 year ]
    Changes in LV hypertrophy


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03520101


Locations
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Canada
IUCPQ
Quebec, Canada, G1V 4G5
Sponsors and Collaborators
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Investigators
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Principal Investigator: Josep Rodés-Cabau, MD Institut universitaire de cardiologie et de pneumologie de Québec
More Information
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Responsible Party: Josep Rodes-Cabau, Principal investigator, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
ClinicalTrials.gov Identifier: NCT03520101    
Other Study ID Numbers: LYTEN
First Posted: May 9, 2018    Key Record Dates
Last Update Posted: February 2, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Aortic Valve Insufficiency
Prosthesis Failure
Aortic Valve Disease
Heart Valve Diseases
 Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Postoperative Complications
Pathologic Processes