Status:
COMPLETED
Safety and Effectiveness Study With a New PDA Occluder for Closure of Patent Ductus Arteriosus
Lead Sponsor:
Occlutech International AB
Conditions:
Patent Ductus Arteriosus
Eligibility:
All Genders
6-70 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- Patients with a demonstrated patent ductus arteriosus
- Female or male
- Belonging to any ethnic group
- Age between \> 6 months and 70 years
- Body weight \> 6 kg \< 120 kg
Exclusion
- Associated congenital cardiac anomalies,
- 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.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01479218
Start Date
November 1 2011
End Date
May 1 2014
Last Update
February 15 2024
Active Locations (2)
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1
IJN National Heart Institute
Kuala Lumpur, Malaysia
2
Pediatric Hospital no 2
Hochiminh City, Vietnam