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

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

Brief Title

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

Official Title

Phase 1 Study for Safety and Effectiveness of the New Occlutech PDA Occluder, for Non Surgical Closure of Patent Ductus Arteriosus

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.
    


Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Successful closure of patent ductus arterious without evidence of any complication assessed by echocardiongram, ECG and X-ray 30 and 90 days after implant.

Secondary Outcome

 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.

Condition

Patent Ductus Arteriosus

Intervention

Occlutech PDA occluder

Study Arms / Comparison Groups

 PDA Occluder
Description:  single arm

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

50

Start Date

November 2011

Completion Date

May 2014

Primary Completion Date

February 2014

Eligibility 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.
      

Gender

All

Ages

6 Months - 70 Years

Accepts Healthy Volunteers

No

Contacts

Ziyad M Hijazi, Professor, , 

Location Countries

Malaysia

Location Countries

Malaysia

Administrative Informations


NCT ID

NCT01479218

Organization ID

Occlutech-PDA1


Responsible Party

Sponsor

Study Sponsor

Occlutech International AB


Study Sponsor

Ziyad M Hijazi, Professor, Study Chair, Rush University medical center, Chicago, USA


Verification Date

May 2013