Post Marketing Clinical Follow Up Study to Evaluate Efficacy and Safety of the Occlutech PDA Occluder in Patients With Patent Ductus Arteriosus Defects

Occlutech International AB255 enrolled

Overview

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.

The Occlutech® PDA Occluder is an occlusion system designed for the percutaneous, catheter based, non surgical closure of Patent Ductus Arteriosus (PDA), and is delivered using the Occlutech Occlusions Pusher (OOP) and Occlutech Delivery Set (ODS), which are recommended as compatible delivery systems. This post marketing clinical follow up study aims to evaluate the safety and efficacy of the Occlutech® PDA Occluder in subjects with PDA. The study is designed as a retrospective and prospective, multicenter, international investigation in which safety and efficacy will be assessed through vital signs, electrocardiography, and echocardiography at baseline/implantation (including assessments performed within 36 hours post procedure), followed by evaluations at Day 30 to Day 90, 6 months to 1 year, 1 to 2 years, and 2 to 3 years after implantation. A total of 217 evaluable subjects is required to estimate a proportion of ≤10% (or ≥90%) with a precision of 4% at an alpha level of 5%, corresponding to a two sided 95% confidence interval width of ≤8%. To account for an anticipated maximum drop out rate of 15%, a total of 255 subjects will be enrolled. Approximately 90% of enrolled participants are expected to be children aged 0-10 years. The primary objective of this study is to assess the safety of the Occlutech® PDA Occluder in subjects requiring transcatheter PDA closure, while the secondary objective is to evaluate the device's efficacy in achieving successful occlusion of the PDA

Study Type

OBSERVATIONAL

Enrollment

255

Conditions

Patent Ductus Arteriosus

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (15)

CHU Sainte-Justine

Montreal, Canada

NOT_YET_RECRUITING

CHU de Lille - Institut Cœur-Poumon

Lille, France

NOT_YET_RECRUITING

Hôpital Mère Enfant, CHU de Nantes

Nantes, France

RECRUITING

Children's Hospital Ireland at Crumlin

Dublin, Ireland

NOT_YET_RECRUITING

Ospedale Pediatrico Bambino Gesù

Roma, Roma, Italy

RECRUITING

Rawalpindi Institute of Cardiology

Rawalpindi, Rawalpindi, Pakistan

RECRUITING

Children´s Hospital, Karolinska University

Stockholm, Sweden

NOT_YET_RECRUITING

Insel Gruppe

Bern, Switzerland

NOT_YET_RECRUITING

Hospital La Rabta

Tunis, Tunisia

RECRUITING

Military Hospital

Tunis, Tunisia

RECRUITING

...and 5 more locations

Outcomes

Primary Outcomes

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.

Time frame: 1 year

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.

Time frame: 2 years

Secondary Outcomes

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.

Time frame: 3 years

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.

Time frame: 3 years

Post Marketing Clinical Follow Up Study to Evaluate Efficacy and Safety of the Occlutech PDA Occluder in Patients With Patent Ductus Arteriosus Defects

Overview

Conditions

Interventions

Eligibility

Locations (15)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts