PMCF Study to Evaluate Efficacy, Safety of the Occlutech PDA Occluder in Patients With Patent Ductus Arteriosus Defects

Launched by OCCLUTECH INTERNATIONAL AB · Mar 2, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a device called the Occlutech PDA Occluder, which is used to close a heart condition known as Patent Ductus Arteriosus (PDA). PDA is a defect in the heart that allows blood to flow improperly between two major arteries. The trial involves both past and current patients and aims to gather information on how well the device works and if it is safe to use. Researchers will monitor patients’ health through various tests and checks at different times after the device is implanted, including within 36 hours, and then at 30 days, 6 months, 1 year, and up to 3 years after the procedure.

Anyone of any age with a PDA may be eligible to participate in the trial, as long as they meet specific medical requirements. However, certain conditions may prevent someone from joining, such as a serious heart or blood vessel problem, a known blood clotting disorder, or an active infection. Participants can expect regular follow-ups to assess their health and the performance of the device after its placement. This study is important because it helps ensure that the Occlutech PDA Occluder is both safe and effective for patients who need this treatment.

Gender

ALL

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