Active — Not RecruitingNot Applicable

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

Canada102 participantsStarted 2017-05-10

Plain-language 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.

Who can participate

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Rate of prothesis-patient mismatch (PPM) (valve performance)

Timeframe: 30 days

Residual transvalvular gradient

Timeframe: 30 days

Trial details

NCT IDNCT03520101

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

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-02-22

View on ClinicalTrials.gov More Aortic Valve Stenosis trials