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

• Sponsor: Occlutech International AB (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01479218
• Collaborator: (none)
• Enrollment: 50
• Locations: 2
• Arm: 1
• Duration (Months): 30
• Patients Per Site: 25
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Patent Ductus Arteriosus	Device: Occlutech PDA occluder	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: Nov 1, 2011
• Actual Primary Completion Date: Feb 1, 2014
• Actual Study Completion Date: May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Other: PDA Occluder single arm	Device: Occlutech PDA occluder; Four different sizes of Occluders will be evaluated based on pre-assessment of PDA size.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Months to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IJN National Heart Institute	Kuala Lumpur		Malaysia
2	Pediatric Hospital no 2	Hochiminh city		Vietnam

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Occlutech International AB
• ClinicalTrials.gov Identifier: NCT01479218
• Other Study ID Numbers: Occlutech-PDA1
• First Posted: Nov 24, 2011
• Last Update Posted: Oct 16, 2014
• Last Verified: May 1, 2013

• Additional relevant MeSH terms: Ductus Arteriosus, Patent

Study Results

No Results Posted as of Oct 16, 2014