Clinical Trial: Closure Of Patent Ductus Arteriosus With the AMPLATZER Duct Occluder the AMPLATZER® Duct Occluder
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title:
Brief Summary: AGA-004 - The objective of the study is to determine safety, effectiveness and clinical utility of the AMPLATZER Duct Occluder in patients with patent ductus arteriosus. AGA-007 - The objective of this study is to evaluate the long term safety and effectiveness issues that may not have have been adequately addressed during AGA-004.
Detailed Summary:
Sponsor: St. Jude Medical
Current Primary Outcome:
- Reporting of Late Adverse Events Relating to the Device. [ Time Frame: Long term follow up for data captured at 5, 6 or 7 years post implant ]
- Reporting of Late Efficacy Issues Regarding Patent Ductus Arteriosis (PDA) Closure [ Time Frame: Long term follow up data captured at 5, 6 or 7 years post implant ]The number of participants with a residual shunt (efficacy)
Original Primary Outcome: The rate of serious and major adverse events will be ≤ 6%. [ Time Frame: 12 months ]
Current Secondary Outcome:
Original Secondary Outcome: The residual patency rate is expected to be < 15% by Doppler color flow mapping and <5% by clinical exam. [ Time Frame: 6 months ]
Information By: St. Jude Medical
Dates:
Date Received: December 20, 2007
Date Started: October 1999
Date Completion:
Last Updated: January 28, 2015
Last Verified: January 2015
