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

Official title

A Multicenter, International, Prospective, Retrospective, Post Marketing Clinical Follow Up Study to Evaluate the Efficacy and Safety of the Occlutech Patent Ductus Arteriosus Occluder (PDA Occluder) in Patients With Patent Ductus Arteriosus Defects

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.

Detailed description

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

Interventions

• Device Occlutech® PDA Occluder
  Non-surgical occlusion of Patent Ductus Arteriosus (PDA).

Primary outcome measures

• Safety primary endpoint [Time frame: 1 year]
• Efficacy primary endpoint [Time frame: 2 years]

Secondary outcome measures (2)

• Safety secondary endpoint [Time frame: 3 years]
• Efficacy secondary endpoint [Time frame: 3 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Other

Study locations

Turkey (Türkiye) · 4 centers

• Aydın Adnan Menderes University Hospital — Aydin
• Eskişehir Osmangazi University Hospital — Eskişehir
• Çukurova University Hospital — Adana
• Dicle University Hospital — Diyarbakır

France · 3 centers

• Hôpital Marie Lannelongue — Le Plessis-Robinson
• CHU de Lille - Institut Cœur-Poumon — Lille
• Hôpital Mère Enfant, CHU de Nantes — Nantes

Tunisia · 2 centers

• Hospital La Rabta — Tunis
• Military Hospital — Tunis

Canada · 1 center

• CHU Sainte-Justine — Montreal

Italy · 1 center

• Ospedale Pediatrico Bambino Gesù — Roma

Pakistan · 1 center

• Rawalpindi Institute of Cardiology — Rawalpindi

Sweden · 1 center

• Children´s Hospital, Karolinska University — Stockholm

Switzerland · 1 center

• Insel Gruppe — Bern

United Kingdom · 1 center

• Royal Brompton & Harefield Hospitals — London

Identifiers

NCT: NCT05264753 · Occ2020_03

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗