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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Home-Based Exercise Program For Recovery After Transcatheter Aortic Valve Replacement Microembolic Signals and Serum Markers of Neuronal Damage During Transcatheter Aortic Valve Implantation. CHANGE Neo™ TA Registry With ACURATE Neo™ Aortic Bioprosthesis and ACURATE Neo™ TA Transapical Delivery System FORWARD PRO Study Interventional Post-market Study With the Evolut™ PRO System SMT Embolic Deflection CE Mark Trial DEFLECT I Echocardiographic Assessment of Cardiovascular Changes in Long Term Space Flight Nitinol Circular Blade Functional Assessment In TAVI: FAITAVI CoreValve VIVA Study Evaluation of the Clinical Outcomes of CoreValve in Degenerative Surgical Aortic Bioprosthesis. POLESTAR Trial – An International Multi-center Early Discharge TAVI Program REPRISE EDGE 29 mm EU Study The CONFIDENCE Registry Interest of Cardiac Computed Tomography to Optimize and Improve the Procedure of TAVI Transapical Implantation of the Medtronic Engager Transcatheter Aortic Valve Implantation System – The Engager European Pivotal Trial Post-Market Follow-up of the CENTERA Transcatheter Heart Valve System SecOnd-generation seLf-expandable Versus Balloon-expandable Valves and gEneral Versus Local Anesthesia in TAVI Balloon Aortic Valvuloplasty During Surgical Aortic Valve Replacement The PROTEMBO SF Trial Adjuvant Radiation in Aortic Valvuloplasty – ARAVA Value of Oral Phytate (InsP6) in the Prevention of Progression of the Cardiovascular Calcifications Supra-Annular vs. Annular ValvEs for Small Annuli Heart Leaflet Technologies Valve Study A Study to Evaluate the Neuro-embolic Consequences of TAVR Femoral vs Radial Approach and MRI Evaluation of Strokes Mortality Post-TAVI and Correlation With Haemodynamic Parameters. 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Evaluated Via Modern Ballistocardiography and Seismocardiography Study of Platelet Activation by Severe Aortic Stenosis and Its Correction by Transcatheter Aortic Valve Implantation Sizing-sTrategy of Bicuspid AoRtic Valve Stenosis With Transcatheter Self-expandable Valve The Plasma Serotonin and Aortic Stenosis: a Pilot Study. 18F-NaF Uptake and Aortic Stenosis Progression Cardiovascular Rehabilitation in Patients With Severe Aortic Stenosis Submitted to Valvar Correction Aortic Stenosis and PhosphodiEsterase Type 5 iNhibition (ASPEN): A Pilot Study Clinical Outcome of Patients With Low-gradient Severe Aortic Stenosis Ultrasonic Markers for Myocardial Fibrosis and Prognosis in Aortic Stenosis Fetal Intervention for Aortic Stenosis and Evolving Hypoplastic Left Heart Syndrome The PARTNER 3 – Trial – The Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis Ventricular Remodeling In Patients With Aortic Stenosis Assessed 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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

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.

Study Type

Interventional

Primary Outcome

Valve performance

Secondary Outcome

 Transvalvular gradient.

Condition

Aortic Valve Stenosis

Intervention

TAVI_ViV procedure with Edwards valve

Study Arms / Comparison Groups

 SAPIEN
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Procedure

Estimated Enrollment

70

Start Date

May 10, 2017

Completion Date

May 31, 2024

Primary Completion Date

September 10, 2020

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

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Josep Rodés-Cabau, MD, 418-656-8711, [email protected]

Location Countries

Canada

Location Countries

Canada

Administrative Informations

NCT ID

NCT03520101

Organization ID

LYTEN

Responsible Party

Principal Investigator

Study Sponsor

Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Study Sponsor

Josep Rodés-Cabau, MD, Principal Investigator, Institut universitaire de cardiologie et de pneumologie de Québec

Verification Date

April 2018