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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

NCT05264753 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 255

Last updated 2026-01-27

No results posted yet for this study

Summary

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.

Conditions

  • Patent Ductus Arteriosus

Interventions

DEVICE

Occlutech® PDA Occluder

Non-surgical occlusion of Patent Ductus Arteriosus (PDA).

Sponsors & Collaborators

  • Occlutech International AB

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-20
Primary Completion
2029-10-25
Completion
2029-11-25

Countries

  • Canada
  • France
  • Ireland
  • Italy
  • Pakistan
  • Sweden
  • Switzerland
  • Tunisia
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05264753 on ClinicalTrials.gov