Evaluating the Occlutech PDA Occluder for Patent Ductus Arteriosus

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study is a multi-center, international, post-marketing follow-up that evaluates the safety and efficacy of the Occlutech PDA Occluder in patients with patent ductus arteriosus (PDA) defects. It involves both retrospective and prospective data collection, assessing vital signs, ECGs, and echocardiography at various time points after the device implantation. The study aims to enroll 255 subjects to ensure a robust analysis of the device's performance over time.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* A subject of any age will be eligible for PDA closure if he or she meets the indication and area of application as laid down in the IFU. Including subjects more than 3 kg. Thus, the Occlutech PDA Occluder is intended for the non-surgical occlusion of Patent Ductus Arteriosus (PDA) defects.
* Male or female subjects.
* Subjects or their parents/guardians understanding the nature of the study and providing their informed consent to participation.
* Subjects willing and able to attend the follow-up visits and procedures foreseen by study CIP.

Exclusion Criteria:

Contraindications as laid down in the IFU:

* Silent ductus or serious pulmonary hypertension:
* Pulmonary Vascular Resistance (PVR) \> 8 Wood Units
* Presence of a known coagulation disorder
* Thrombus at the position allocated for the implantation
* A vein thrombosis in the blood vessels chosen for the introducing system
* An active infection (active endocarditis or other infections causing bacteremia) or history of endocarditis within 3 months from the procedure.
* Nitinol intolerance (nickel or titanium)
* Contrast medium intolerance
* Subjects who have a vascular system (which is used to access the defect) that is too small to admit the required sheath

Where it's running

• Hôpital Mère Enfant, CHU de Nantes
  Nantes, France Recruiting
• Ospedale Pediatrico Bambino Gesù
  Roma, Roma, Italy Recruiting
• Rawalpindi Institute of Cardiology
  Rawalpindi, Rawalpindi, Pakistan Recruiting
• Children´s Hospital, Karolinska University
  Stockholm, Sweden Recruiting
• Hospital La Rabta
  Tunis, Tunisia Recruiting
• Military Hospital
  Tunis, Tunisia Recruiting

Study contacts

• Study coordinator: Ahmed Dellaa, PhD
• Email: ahmed.dellaa@occlutech.com
• Phone: +49 3641 508 367

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• HeartR PDA Occluder: Long-Term Follow-Up in Indonesian Patients

  This study tests how the HeartR PDA Occluder performs and stays safe in real-world use for children and adults with patent ductus arteriosus in Indonesia.

  Recruiting Lifetech Scientific (Shenzhen) Co., Ltd. · Pekanbaru, Riau · NCT07646704

• Precision dosing of oral ibuprofen to close PDA in very preterm newborns

  This study will test whether adjusting oral ibuprofen doses for each very preterm baby using blood levels and echocardiograms helps close a patent ductus arteriosus more often than the standard fixed dose.

  Recruiting Phase 2 Hamilton Health Sciences Corporation · Hamilton, Ontario · NCT07143201

• New ultrasound technology for monitoring brain blood flow in sick newborns

  This study is testing a new ultrasound technology to see if it can help monitor blood flow in the brains of sick newborns and preterm infants.

  Recruiting St. Olavs Hospital · Trondheim · NCT06646250

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.