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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PDA Occluder | Other | single arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Occlutech PDA occluder | Device | Four different sizes of Occluders will be evaluated based on pre-assessment of PDA size. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
General exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Ziyad M Hijazi, Professor | Rush University medical center, Chicago, USA | Study Chair |
| Alwi Mazeni, Dr | IJN Heart Institute, Kuala Lumpur, Malaysia | Principal Investigator |
| Viet Minh Tri Nguyen, Dr | Pediatric hospital no 2, Hochiminh city, Vietnam | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IJN National Heart Institute | Kuala Lumpur | Malaysia | ||||
| Pediatric Hospital no 2 |
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| ID | Term |
|---|---|
| D004374 | Ductus Arteriosus, Patent |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
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| Hochiminh City |
| Vietnam |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |