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

This study has been completed.
Information provided by (Responsible Party):
Occlutech International AB Identifier:
First received: November 18, 2011
Last updated: October 15, 2014
Last verified: May 2013
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

Resource links provided by NLM:

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 ]

Enrollment: 50
Study Start Date: November 2011
Study Completion Date: May 2014
Primary Completion Date: February 2014 (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.


Ages Eligible for Study:   6 Months to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01479218

IJN National Heart Institute
Kuala Lumpur, Malaysia
Pediatric Hospital no 2
Hochiminh city, Vietnam
Sponsors and Collaborators
Occlutech International AB
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 Identifier: NCT01479218     History of Changes
Other Study ID Numbers: Occlutech-PDA1
Study First Received: November 18, 2011
Last Updated: October 15, 2014
Health Authority: Malaysia: Institutional Review Board

Additional relevant MeSH terms:
Ductus Arteriosus, Patent
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities
Heart Defects, Congenital
Heart Diseases processed this record on November 24, 2015