Clinical trial NCT05264753: PMCF Study to Evaluate Efficacy, Safety of the Occlutech PDA Occluder in Patients With Patent Ductus Arteriosus Defects
Official title: A Multicenter, International, Prospective,Retrospective, PMCF Study to Evaluate the Efficacy and Safety of the Occlutech Patent Ductus Arteriosus Occluder (PDA Occluder) in Patients With Patent Ductus Arteriosus Defects
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Patent Ductus Arteriosus
Lead sponsor: Occlutech International AB
Sponsor class: INDUSTRY
First posted: 2022-03-03
Enrollment: 255
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Full Analysis Set (safety): All patients intended to be treated with PDA Full Analysis Set (efficacy): All patients with implanted PDA

Brief summary: This is a retrospective and prospective, multi-center, international, post marketing follow-up study to evaluate the safety and efficacy of the Occlutech PDA by using Occlutech Occlusions-Pusher (OOP) in patients with patent ductus arteriosus defects.

Efficacy and safety of implanted device(s) will be evaluated by vital signs, ECGs, and echocardiography data on baseline/implantation visit (include assessments within 36 hrs. post-procedure), Day 30 to Day 90, 6 months to 1 year, 2 years to 3 years after implantation.

Detailed description: Indication 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 (PDA) .Occlutech Occlusions-Pusher (OOP) and Occlutech Delivery Set (ODS) are recommended as delivery systems.

Study purpose This study aims to evaluate the safety and efficacy of The Occlutech PDA Occluder devices in patients with patent ductus arteriosus defects (PDA).

Study design This is a retrospective and prospective, multi-center, international, post marketing follow-up study to evaluate the safety and efficacy of the Occlutech® PDA occlude in subjects with patent ductus arteriosus defects.

Efficacy and safety of implanted device(s) will be evaluated by vital signs, ECGs, and echocardiography data on baseline/implantation visit (include assessments within 36 hrs. post-procedure), Day 30 to Day 90, 6 months to 1 year, 2 years to 3 years after implantation.

A sample size of N = 217 evaluable subjects will allow to estimate a proportion of ≤10% (or ≥90%) with precision of 4% at an alpha level of 5%. I.e., the total width of the two-sided 95%-confidence interval will be ≤8%.

Accounting for an anticipated, maximum drop-out (e.g., patients being not evaluable for the primary endpoints due to missing follow-up) rate of 15%, a total number of 255 subjects needs to be enrolled. Besides, N=217 evaluable patients guarantee two-sided 95%-CIs for continuous variables' means having a width of \~0.27 standard deviations (SD). This precision is sufficient for the descriptive objectives.

255 subjects treated for the non-surgical occlusion of PDA with the Occlutech® PDA Occluder. One should note that the majority (\~ 90%) of the subjects will be children of young age (0-10 years).

Study objectives To evaluate the safety of the Occlutech® PDA Occluder in subjects requiring transcatheter occlusion (closure) of Patent Ductus Arteriosus.

To evaluate the efficacy of the Occlutech® PDA Occluder in subjects requiring transcatheter occlusion (closure) of Patent Ductus Arteriosus.

Eligibility criteria: Inclusion Criteria:

* A patient 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. Thus, the Occlutech PDA Occluder is intended for the non-surgical occlusion of Patent Ductus Arteriosus (PDA).

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
* Patients who have a vascular system (which is used to access the defect) that is too small to admit the required sheath

Primary outcomes:
measure: Safety primary endpoint
timeFrame: 1 year
measure: Efficacy primary endpoint
timeFrame: 2 years
Secondary outcomes:
measure: Safety secondary endpoint
timeFrame: 3 years
measure: Efficacy secondary endpoint
timeFrame: 3 years
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Ospedale Pediatrico Bambin Gesù
city: Rawalpindi
country: Pakistan
facility: Rawalpindi Institute of Cardiology
city: Tunis
country: Tunisia
facility: Military Hospital
city: Aydın
country: Turkey
facility: Aydın Adnan Menderes University Hospital
state: Efeler
city: Adana
country: Turkey
facility: Çukurova University Hospital
state: Sarıçam
city: Diyarbakır
country: Turkey
facility: Dicle University Hospital
state: SUR
city: Eskişehir
country: Turkey
facility: Eskişehir Osmangazi University Hospital
city: London
country: United Kingdom
facility: Royal Brompton & Harefield Hospitals
Study officials:
References: