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A Multicenter, International, Prospective and Retrospective, Follow-up Registry to Monitor the Efficacy and Safety of the Occlutech Paravalvular Leak Device (PLD) in Patients With Mitral or Aortic Paravalvular Leaks

Study acronym: PLD REGISTRY
StatusEnrolling by Invitation
PhaseNot specified
Started
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Record History

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  1. Trial sites expanded: 9 → 22 locations
    • Study description shortened, about 1,377 words
    v3
  2. Study sites: 1 to 9v2
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is an international, multicenter, retrospective and prospective post-marketing follow-up registry designed to monitor the safety and efficacy of the Occlutech Paravalvular Leak Device (PLD) in patients with clinically significant mitral or aortic paravalvular leaks after previously implanted prosthetic heart valves who undergo transcatheter PVL closure in routine clinical practice. Up to 200 subjects are planned to be enrolled and followed after the procedure (Day 1-7, Day 30, 6-12 months, and annually up to 3 years) to evaluate device safety (including serious adverse device effects) and effectiveness, including reduction of paravalvular regurgitation assessed by echocardiography and clinical outcomes such as improvement in heart failure symptoms and/or reduced need for hemolysis-related transfusions.
Trial Details
NCT Number NCT07037446
Lead Sponsor Occlutech International AB
Conditions
(from sponsor)		 Paravalvular Leak
Related terms Leukomalacia, Periventricular
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov