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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01479218
Other study ID # Occlutech-PDA1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2011
Est. completion date May 2014

Study information

Verified date May 2013
Source Occlutech International AB
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date May 2014
Est. primary completion date February 2014
Accepts healthy volunteers No
Gender All
Age group 6 Months to 70 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Device:
Occlutech PDA occluder
Four different sizes of Occluders will be evaluated based on pre-assessment of PDA size.

Locations

Country Name City State
Malaysia IJN National Heart Institute Kuala Lumpur
Vietnam Pediatric Hospital no 2 Hochiminh city

Sponsors (1)

Lead Sponsor Collaborator
Occlutech International AB

Countries where clinical trial is conducted

Malaysia,  Vietnam, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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