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

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

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Quebec, Canada, G1V 4G5
        • IUCPQ

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
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.
Other: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of prothesis-patient mismatch (PPM) (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).
30 days
Residual transvalvular gradient
Time Frame: 30 days
Residual (maximal and mean) transvalvular gradient.
30 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Josep Rodés-Cabau, MD, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2017

Primary Completion (Actual)

February 22, 2022

Study Completion (Estimated)

May 31, 2024

Study Registration Dates

First Submitted

May 8, 2017

First Submitted That Met QC Criteria

April 26, 2018

First Posted (Actual)

May 9, 2018

Study Record Updates

Last Update Posted (Actual)

December 20, 2023

Last Update Submitted That Met QC Criteria

December 19, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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