Clinical Trial: AMPLATZER Duct Occluder II Clinical Study

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Closure of Patent Ductus Arteriosus With the AMPLATZER DUCT Occluder II

Brief Summary: The objective of this study is to investigate the safety and effectiveness of the ADO II in patients with a PDA.

Detailed Summary:
Sponsor: St. Jude Medical

Current Primary Outcome:

• The Primary Safety Endpoint is the Rate of Device and Procedure Related Serious Adverse Events (SAE) 180 Days Post Procedure. [ Time Frame: 180 days ]

  The primary safety endpoint is the rate of device and/or procedure related SAEs reported in subjects whom device placement is attempted from the procedure through 180 days post procedure

  SAEs are defined as: Adverse events resulting in the following; death, life-threatening adverse event, inpatient hospitalization or prolongation of existing hospital stay, persistent or significant disability/incapacity or medically significant event.

• The Primary Effectiveness Endpoint is the Rate of Complete Closure of the Ductus Arteriosus at the Six-month Follow-up. [ Time Frame: 180 days ]
  The primary efficacy endpoint is the rate of complete closure of the ductus arteriosus as assessed by the absence of residual flow and continuous murmur at the six-month follow-up by transthoracic echocardiography and physical exam respectively.

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: St. Jude Medical

Dates:
Date Received: July 9, 2008
Date Started: August 2008
Date Completion: January 2017
Last Updated: June 8, 2016
Last Verified: June 2016