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

Study Overview
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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.

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

Conditions
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Aortic Valve Stenosis, Regurgitation, Aortic, Prosthesis Failure

Intervention / Treatment
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* Procedure: TAVI_ViV procedure with Edwards valve
* Procedure: TAVI_ViV procedure with CoreValve system


Participation Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: SAPIEN<br>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<br>* 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.<br>|
| Other: COREVALVE<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transvalvular gradient. | Maximal and mean transvalvular gradient | 1-year | 
| Valve performance : Moderate or severe PPM moderate-severe AR at 30 days and 1 year. | Moderate or severe PPM; moderate-severe AR. | 30 days and 1 year | 
| Combined endpoints: Moderate-severe AR or severe PPM at 1-year follow-up. | Moderate-severe AR or severe PPM. | 1 year | 
| Clinical safety endpoints | individually and combined: death, stroke, major or life threatening bleeding, pacemaker implantation, myocardial infarction. | 30 days and 1 year | 
| Exercise capacity | Exercise capacity as evaluated by the six-minute walk test | 30 days and 1 year | 
| Changes in LV hypertrophy | Changes in LV hypertrophy | 30 days and 1 year |