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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Occlutech International AB
ClinicalTrials.gov Identifier:
NCT01479218
First received: November 18, 2011
Last updated: May 30, 2013
Last verified: May 2013
  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

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 ]

Estimated Enrollment: 50
Study Start Date: November 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 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.

  Eligibility

Ages Eligible for Study:   6 Months to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01479218

Locations
Malaysia
IJN National Heart Institute
Kuala Lumpur, Malaysia
Vietnam
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
  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: May 30, 2013
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 August 28, 2014