Safety and Effectiveness Study With a New PDA Occluder for Closure of Patent Ductus Arteriosus

Occlutech

Status: Completed

Conditions: Patent Ductus Arteriosus

Treatments: Device: Occlutech PDA occluder

Study type: Interventional

Funder types: Industry

Identifiers

NCT01479218

Occlutech-PDA1

Details and patient eligibility

About

The objective of the study is to investigate the safety, efficacy and clinical utility of the Occlutech PDA device for closure of patent ductus arteriosus of all types.

Enrollment: 50 patients

Sex: All

Ages: 6 months to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with a demonstrated patent ductus arteriosus
2. Female or male
3. Belonging to any ethnic group
4. Age between > 6 months and 70 years
5. Body weight > 6 kg < 120 kg

Exclusion criteria

1. Associated congenital cardiac anomalies,
2. Body weight < 6 Kilograms

General exclusion criteria

• 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
• Nitinol intolerance (nickel or titanium)
• contrast medium intolerance
• patients who have a vascular system which is too small to admit the required sheath
• patients with pulmonary hypertension and pulmonary-vascular resistance of >8 Woods Units or a lung - / systemic resistance (PR/SR) of >0.4.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

PDA Occluder

Other group

Description:

single arm

Treatment:

Device: Occlutech PDA occluder