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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03520101
Other study ID # LYTEN
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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