ClinicaliQ Trial Snapshot
- Post Marketing Clinical Follow Up Study to Evaluate Efficacy and Safety of the Occlutech PDA Occluder in Patients With Patent Ductus Arteriosus Defects — Recruiting • Cardiology / Cardiovascular • NCT05264753.
- What is being tested: The Occlutech PDA Occluder device and delivery system for transcatheter closure of patent ductus arteriosus (PDA), with evaluation of both safety and efficacy outcomes through retrospective and prospective data collection across multiple international centres.
- Patient eligibility overview: The study includes subjects diagnosed with patent ductus arteriosus defects suitable for percutaneous transcatheter closure, though specific anatomical, age, and haemodynamic criteria would be defined in the full protocol.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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.
Eligibility Snapshot
- : * 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.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.