Safety and Effectiveness Study With a New PDA Occluder for Closure of Patent Ductus Arteriosus
1 other identifier
interventional
50
2 countries
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2011
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 18, 2011
CompletedFirst Posted
Study publicly available on registry
November 24, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedFebruary 15, 2024
May 1, 2013
2.3 years
November 18, 2011
February 13, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Study Arms (1)
PDA Occluder
OTHERsingle arm
Interventions
Four different sizes of Occluders will be evaluated based on pre-assessment of PDA size.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Associated congenital cardiac anomalies,
- Body weight \< 6 Kilograms
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
IJN National Heart Institute
Kuala Lumpur, Malaysia
Pediatric Hospital no 2
Hochiminh City, Vietnam
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ziyad M Hijazi, Professor
Rush University medical center, Chicago, USA
- PRINCIPAL INVESTIGATOR
Alwi Mazeni, Dr
IJN Heart Institute, Kuala Lumpur, Malaysia
- PRINCIPAL INVESTIGATOR
Viet Minh Tri Nguyen, Dr
Pediatric hospital no 2, Hochiminh city, Vietnam
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2011
First Posted
November 24, 2011
Study Start
November 1, 2011
Primary Completion
February 1, 2014
Study Completion
May 1, 2014
Last Updated
February 15, 2024
Record last verified: 2013-05