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NCT05264753
Post Marketing Clinical Follow Up Study to Evaluate Efficacy and Safety of the Occlutech PDA Occluder in Patients With Patent Ductus Arteriosus Defects
trial testing Occlutech® PDA Occluder in Patent Ductus Arteriosus in 255 participants. Currently enrolling.
25 October 2029
Quick facts
| Lead sponsor | Occlutech International AB |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 255 |
| Start date | 20 December 2021 |
| Primary completion | 25 October 2029 |
| Estimated completion | 25 November 2029 |
| Sites | 15 locations across Tunisia, France, Pakistan, Italy, Sweden, Ireland, United Kingdom, Canada |
Drugs / interventions tested
- Occlutech® PDA Occluder
Conditions studied
- Patent Ductus Arteriosus — all drugs for Patent Ductus Arteriosus →
Sponsor
Occlutech International AB — full company profile →
Who can join
Eligibility, any sex, with Patent Ductus Arteriosus. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05264753
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Patent Ductus Arteriosus
Currently open trials in the same condition.
- NCT06646250 — NeoDoppler: New Ultrasound Technology for Continuous Monitoring of Cerebral Circulation Pilot · recruiting
- NCT04371081 — Amplatzer Piccolo Occluder Japan Post-marketing Database Surveillance · active not recruiting
- NCT03456336 — Management of the PDA Trial · Phase 3 · active not recruiting
Other Occlutech International AB trials
Trials by the same sponsor.
- NCT07037446 — A Multicenter, International, Prospective and Retrospective, Follow-up Registry to Monitor the Efficacy and Safety of th · enrolling by invitation
- NCT05329350 — Follow-up Study to Monitor the Efficacy and Safety of the Occlutech® mVSD Cases · recruiting
- NCT05174442 — ACCESS Registry: A Post Market Follow-up Study to Monitor the Safety, Performance and Usability of Occlutech Accessory M · recruiting
- NCT04029233 — The PROOF Trial - Prospective, Open-label, Multicenter, Non-randomized Investigation on Percutaneous Patent Foramen Oval · terminated
- NCT03030274 — The Prelieve Trial - Pilot Study to Assess Safety and Efficacy of a Novel Atrial Flow Regulator (AFR) in Heart Failure P · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05264753 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Occlutech International AB
- Last refreshed: 27 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05264753.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing