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

Patent Ductus Arteriosus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01479218
• Other study ID #: Occlutech-PDA1
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Ductus Arteriosus, Patent
• Patent Ductus Arteriosus

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