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

Not Applicable

Completed

• Conditions: Patent Ductus Arteriosus
• Interventions: Device: Occlutech PDA occluder

• Registration Number: NCT01479218
• Lead Sponsor: Occlutech International AB

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-18
• Study First Submitted QC: 2011-11-23
• Study First Posted: 2011-11-24
• Status Verified: 2013-05
• Primary Completion: 2014-02
• Study Completion: 2014-05
• Last Update Submitted: 2024-02-13
• Last Update Posted: 2024-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PDA Occluder	Occlutech PDA occluder	single arm

Primary Outcome Measures

Name	Time	Method
Successful closure of patent ductus arterious without evidence of any complication assessed by echocardiongram, ECG and X-ray 30 and 90 days after implant.	3 months

Secondary Outcome Measures

Name	Time	Method
Successful closure without evidence of residual shunt after 1 year confirmed by echocariodgram. Safety: freedom of major adverse events i.e periherial embolism or endocarditits.	30, 90, 180 and 360 days after implant

Trial Locations

Locations (2)

Pediatric Hospital no 2; 🇻🇳 Hochiminh city, Vietnam

IJN National Heart Institute; 🇲🇾 Kuala Lumpur, Malaysia