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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Four different sizes of Occluders will be evaluated based on pre-assessment of PDA size.
IJN National Heart Institute
Kuala Lumpur, Malaysia
Pediatric Hospital no 2
Hochiminh City, Vietnam
Successful closure of patent ductus arterious without evidence of any complication assessed by echocardiongram, ECG and X-ray 30 and 90 days after implant.
Time frame: 3 months
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.
Time frame: 30, 90, 180 and 360 days after implant
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.