Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT03520101 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this 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. The 'LYTEN' Trial

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Study completion date: May 31, 2024 to May 31, 2030
    • Secondary endpoints: details revised at 6 of 6 entries
    • Site details revised
    v7
  2. Re-verified, no change to tracked fieldsv6
  3. Primary endpoints revised (2)v5
  4. Re-verified, no change to tracked fieldsv4
  5. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 100 to confirmed 102
    • Primary completion date: Feb 10, 2022 to Feb 22, 2022
    • Site details revised
    v3
  6. Primary completion date: Sep 10, 2020 to Feb 10, 2022
    • Enrollment target: 70 to 100
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03520101
Lead Sponsor Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Conditions
(from sponsor)		 Aortic Valve Stenosis, Regurgitation, Aortic, Prosthesis Failure
Related terms Aortic Valve Insufficiency, Aortic Valve Stenosis, Prosthesis Failure
Enrollment 102 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov