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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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.

Detailed Summary:
Sponsor: Occlutech International AB

Current 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. [ Time Frame: 3 months ]

Original Primary Outcome: Same as current

Current 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. [ Time Frame: 30, 90, 180 and 360 days after implant ]

Original Secondary Outcome: Same as current

Information By: Occlutech International AB

Dates:
Date Received: November 18, 2011
Date Started: November 2011
Date Completion:
Last Updated: October 15, 2014
Last Verified: May 2013