Clinical Trial: Closure of Atrial Septal Defects With the AMPLATZER Septal Occluder - Post Approval Study

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title:

Brief Summary: The purpose of this study is to prospectively evaluate the incidence of hemodynamic compromise and to obtain long-term survival data on patients with the AMPLATZER Septal Occluder

Detailed Summary:
Sponsor: St. Jude Medical

Current Primary Outcome: The primary objective is to evaluate the risk of hemodynamic compromise in patients who receive the AMPLATZER Septal Occluder device. [ Time Frame: 24 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: The co-primary objective is to assess the safety and effectiveness of the AMPLATZER Septal Occluder device and delivery system. [ Time Frame: 24 months ]

Original Secondary Outcome: Same as current

Information By: St. Jude Medical

Dates:
Date Received: March 31, 2008
Date Started: August 2007
Date Completion: June 2015
Last Updated: January 30, 2015
Last Verified: January 2015