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Post Marketing Clinical Follow Up Study to Evaluate Efficacy and Safety of the Occlutech PDA Occluder in Patients With Patent Ductus Arteriosus Defects

StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Site contacts updated at 15 of 15 sitesv5
  2. Study sites revised (15)v4
  3. Primary completion date: Oct 25, 2026 to Oct 25, 2029v3 Show 5 more changesShow less
    • Study sites: 8 to 15
    • Study completion date: Nov 25, 2026 to Nov 25, 2029
    • Eligibility criteria expanded, about 43 words
    • Study description shortened, about 78 words
    • Study title expanded, about 5 words
  4. Enrollment target: 100 to 255v2 Show 6 more changesShow less
    • Primary completion date: Nov 25, 2022 to Oct 25, 2026
    • Study sites: 3 to 8
    • Study completion date: Nov 25, 2025 to Nov 25, 2026
    • Secondary endpoints expanded, about 6 words
    • Primary endpoints revised (2)
    • Study description shortened, about 33 words
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 retrospective and prospective, multicenter, international post marketing follow up study evaluates the safety and efficacy of the Occlutech® PDA Occluder, delivered using the Occlutech Occlusions Pusher (OOP), in subjects with patent ductus arteriosus (PDA) defects. Safety and efficacy assessments include vital signs, electrocardiograms, and echocardiographic evaluations performed at baseline/implantation (including assessments within 36 hours post procedure), as well as at follow up visits occurring between Day 30 and Day 90, 6 months to 1 year, 1 to 2 years, and 2 to 3 years after implantation.
Trial Details
NCT Number NCT05264753
Lead Sponsor Occlutech International AB
Conditions
(from sponsor)		 Patent Ductus Arteriosus
Related terms Ductus Arteriosus, Patent
Enrollment 255 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov