Safety and Effectiveness Study With a New PDA Occluder for Closure of Patent Ductus Arteriosus
This study is currently recruiting participants.
Verified December 2011 by Occlutech International AB
Sponsor:
Occlutech International AB
Information provided by (Responsible Party):
Occlutech International AB
ClinicalTrials.gov Identifier:
NCT01479218
First received: November 18, 2011
Last updated: December 8, 2011
Last verified: December 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Patent Ductus Arteriosus |
Device: Occlutech PDA occluder |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase 1 Study for Safety and Effectiveness of the New Occlutech PDA Occluder, for Non Surgical Closure of Patent Ductus Arteriosus |
Further study details as provided by Occlutech International AB:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 50 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
PDA Occluder
single arm
|
Device: Occlutech PDA occluder
Four different sizes of Occluders will be evaluated based on pre-assessment of PDA size.
|
Eligibility| Ages Eligible for Study: | 6 Months to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Associated congenital cardiac anomalies,
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01479218
Contacts
| Contact: Zijad M Hijazi, Professor | zhijazi@rush.edu |
Locations
| Malaysia | |
| IJN National Heart Institute | Recruiting |
| Kuala Lumpur, Malaysia | |
| Contact: Ziyad M Hijazi, Professor zhijazi@rush.edu | |
| Vietnam | |
| Pediatric Hospital no 2 | Not yet recruiting |
| Hochiminh city, Vietnam | |
| Contact: Zijad m Hijazi, Professor zhijazi@rush.edu | |
Sponsors and Collaborators
Occlutech International AB
Investigators
| 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 |
More Information
No publications provided
| Responsible Party: | Occlutech International AB |
| ClinicalTrials.gov Identifier: | NCT01479218 History of Changes |
| Other Study ID Numbers: | Occlutech-PDA1 |
| Study First Received: | November 18, 2011 |
| Last Updated: | December 8, 2011 |
| Health Authority: | Malaysia: Institutional Review Board |
Additional relevant MeSH terms:
|
Ductus Arteriosus, Patent Heart Defects, Congenital Cardiovascular Abnormalities |
Cardiovascular Diseases Heart Diseases Congenital Abnormalities |
ClinicalTrials.gov processed this record on May 16, 2013