PDA study v 1.2
Research type
Research Study
Full title
A MULTICENTER, INTERNATIONAL, PROSPECTIVE and RETROSPECTIVE, POST MARKETING CLINICAL FOLLOW-UP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE OCCLUTECH PATENT DUCTUS ARTERIOSUS OCCLUDER (THE OCCLUTECH PDA OCCLUDER) IN PATIENT WITH PATENT DUCTUS ARTERIOSUS DEFECTS
IRAS ID
318495
Contact name
Alain Fraisse
Contact email
Sponsor organisation
Occlutech International AB
Clinicaltrials.gov Identifier
Duration of Study in the UK
7 years, 5 months, 0 days
Research summary
The patent ductus arteriosus (PDA) is a vascular structure connecting the proximal descending aorta to the left pulmonary artery near its origin. This essential fetal structure closes spontaneously in 90% of full-term newborns. After the first weeks of life, the persistence of ductal patency is abnormal. PDA is defined as congenital heart disease, in which there is persistent patency beyond the third month of life in term infants. PDA can be associated with various other congenital heart diseases. In adults, PDA is often an isolated lesion.
This is a retrospective and prospective, multi-center, international, post marketing follow-up study to evaluate the safety and efficacy of the Occlutech PDA Occluder in patients with Patent Ductus Arteriosus defects. The Occlutech PDA Occluder is an occlusion system, which is percutaneously implanted through a catheter intervention technique and intended for the non-surgical occlusion of Patent Ductus Arteriosus.
Efficacy and safety of implanted device(s) will be evaluated, following the normal clinical practice, by vital signs, ECGs, and echocardiography data on Day 1 (within 36 hrs. post-procedure), Day 30 to Day 90, 6 months to 1 year, 2 years to 3 years, and 4 to 5 years after implantation.
100 patients reated for the non-surgical occlusion of PDA with the Occlutech PDA Occluder will be enrolled and the majority (~ 90%) of the patients will be children of young age (0 - 10years).REC name
HSC REC B
REC reference
23/NI/0013
Date of REC Opinion
23 Feb 2023
REC opinion
Favourable Opinion