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
Primary Purpose
Aortic Valve Stenosis, Regurgitation, Aortic, Prosthesis Failure
Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
TAVI_ViV procedure with Edwards valve
TAVI_ViV procedure with CoreValve system
Sponsored by
About this trial
This is an interventional treatment trial for Aortic Valve Stenosis
Eligibility 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
Sites / Locations
- IUCPQ
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
SAPIEN
COREVALVE
Arm Description
Following the Heart Team's decision to proceed with a TAVI-ViV procedure, patients will received an Edwards (SAPIEN XT or SAPIEN 3) valve.
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.
Outcomes
Primary Outcome Measures
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).
Residual transvalvular gradient
Residual (maximal and mean) transvalvular gradient.
Secondary Outcome Measures
Transvalvular gradient.
Maximal and mean transvalvular gradient
Valve performance : Moderate or severe PPM moderate-severe AR at 30 days and 1 year.
Moderate or severe PPM; moderate-severe AR.
Combined endpoints: Moderate-severe AR or severe PPM at 1-year follow-up.
Moderate-severe AR or severe PPM.
Clinical safety endpoints
individually and combined: death, stroke, major or life threatening bleeding, pacemaker implantation, myocardial infarction.
Exercise capacity
Exercise capacity as evaluated by the six-minute walk test
Changes in LV hypertrophy
Changes in LV hypertrophy
Full Information
NCT ID
NCT03520101
First Posted
May 8, 2017
Last Updated
July 12, 2022
Sponsor
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
1. Study Identification
Unique Protocol Identification Number
NCT03520101
Brief 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. The 'LYTEN' Trial
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 10, 2017 (Actual)
Primary Completion Date
February 22, 2022 (Actual)
Study Completion Date
May 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
4. Oversight
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
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Stenosis, Regurgitation, Aortic, Prosthesis Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SAPIEN
Arm Type
Other
Arm Description
Following the Heart Team's decision to proceed with a TAVI-ViV procedure, patients will received an Edwards (SAPIEN XT or SAPIEN 3) valve.
Arm Title
COREVALVE
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
TAVI_ViV procedure with Edwards valve
Intervention Description
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
Intervention Name(s)
TAVI_ViV procedure with CoreValve system
Intervention Description
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 Outcome Measure Information:
Title
Rate of prothesis-patient mismatch (PPM) (valve performance)
Description
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).
Time Frame
30 days
Title
Residual transvalvular gradient
Description
Residual (maximal and mean) transvalvular gradient.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Transvalvular gradient.
Description
Maximal and mean transvalvular gradient
Time Frame
1-year
Title
Valve performance : Moderate or severe PPM moderate-severe AR at 30 days and 1 year.
Description
Moderate or severe PPM; moderate-severe AR.
Time Frame
30 days and 1 year
Title
Combined endpoints: Moderate-severe AR or severe PPM at 1-year follow-up.
Description
Moderate-severe AR or severe PPM.
Time Frame
1 year
Title
Clinical safety endpoints
Description
individually and combined: death, stroke, major or life threatening bleeding, pacemaker implantation, myocardial infarction.
Time Frame
30 days and 1 year
Title
Exercise capacity
Description
Exercise capacity as evaluated by the six-minute walk test
Time Frame
30 days and 1 year
Title
Changes in LV hypertrophy
Description
Changes in LV hypertrophy
Time Frame
30 days and 1 year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josep Rodés-Cabau, MD
Organizational Affiliation
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Official's Role
Principal Investigator
Facility Information:
Facility Name
IUCPQ
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
35597385
Citation
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. Erratum In: J Am Coll Cardiol. 2022 Oct 4;80(14):1419.
Results Reference
derived
Learn more about this trial
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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