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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05264753
Other study ID # Occ2020_03
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 20, 2021
Est. completion date November 25, 2026

Study information

Verified date June 2023
Source Occlutech International AB
Contact Hussa Al Othman
Phone +49 3641 508 365
Email hussa.alothman@occlutech.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 255
Est. completion date November 25, 2026
Est. primary completion date October 25, 2026
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Italy Ospedale Pediatrico Bambin Gesù Roma
Pakistan Rawalpindi Institute of Cardiology Rawalpindi
Tunisia Military Hospital Tunis
Turkey Çukurova University Hospital Adana Sariçam
Turkey Aydin Adnan Menderes University Hospital Aydin Efeler
Turkey Dicle University Hospital Diyarbakir SUR
Turkey Eskisehir Osmangazi University Hospital Eskisehir
United Kingdom Royal Brompton & Harefield Hospitals London

Sponsors (1)

Lead Sponsor Collaborator
Occlutech International AB

Countries where clinical trial is conducted

Italy,  Pakistan,  Tunisia,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety primary endpoint The primary safety endpoint is defined as the incidence of any Serious Adverse Device Effects (SADEs) including procedure-related death, procedure-related stroke, systemic embolism, severe hemolysis, device embolization, cardiac tamponade, infective endocarditis, or vascular complications requiring surgery up to 1-year post-implantation. 1 year
Primary Efficacy primary endpoint The primary efficacy endpoint is defined as successful implantation of the Occlutech® PDA Occluder with a complete closure of the PDA (defined as >90% PDA closure represented by no or small residual flow) as assessed by echocardiography post-implantation) within 2-year post- implantation follow-up. 2 years
Secondary Safety secondary endpoint Secondary safety endpoints will assess all minor complications such as transient hemolysis, vascular complications not requiring surgery, or all minor complications which are deemed relevant at the discretion of each investigator. Additionally, an assessment of all Serious Adverse Events (SAE) will be included in the analyses. 3 years
Secondary Efficacy secondary endpoint Secondary efficacy assessments refer to the variation in the data from baseline to 3 years after the procedure in parameters such as, but not limited to, aortic blood pressure, pulse rate, LVFS, pulmonary artery pressure, and ECG records. 3 years
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