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

Aortic Valve Stenosis Clinical 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03520101
• Other study ID #: LYTEN
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 10, 2017
• Est. completion date: May 31, 2024

Study information

• Verified date: December 2023
• Source: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 102
• Est. completion date: May 31, 2024
• Est. primary completion date: February 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Insufficiency
• Aortic Valve Stenosis
• Prosthesis Failure
• Regurgitation, Aortic

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	IUCPQ	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Residual transvalvular gradient	Residual (maximal and mean) transvalvular gradient.	30 days
Secondary	Transvalvular gradient.	Maximal and mean transvalvular gradient	1-year
Secondary	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
Secondary	Combined endpoints: Moderate-severe AR or severe PPM at 1-year follow-up.	Moderate-severe AR or severe PPM.	1 year
Secondary	Clinical safety endpoints	individually and combined: death, stroke, major or life threatening bleeding, pacemaker implantation, myocardial infarction.	30 days and 1 year
Secondary	Exercise capacity	Exercise capacity as evaluated by the six-minute walk test	30 days and 1 year
Secondary	Changes in LV hypertrophy	Changes in LV hypertrophy	30 days and 1 year