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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01479218
Recruitment Status : Completed
First Posted : November 24, 2011
Last Update Posted : October 16, 2014
Sponsor:
Information provided by (Responsible Party):

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  (Clinical Trial)
Actual Enrollment : 50 participants
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 : November 2011
Primary Completion Date : February 2014
Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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. [ Time Frame: 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. [ Time Frame: 30, 90, 180 and 360 days after implant ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Occlutech International AB
ClinicalTrials.gov Identifier: NCT01479218     History of Changes
Other Study ID Numbers: Occlutech-PDA1
First Posted: November 24, 2011    Key Record Dates
Last Update Posted: October 16, 2014
Last Verified: May 2013

Additional relevant MeSH terms:
Ductus Arteriosus, Patent
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities