Clinical Trial: Closure of Muscular Ventricular Septal Defects (VSDs) With the AMPLATZER Muscular VSD (MuVSD) Occluder - Post Approval Study

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title:

Brief Summary: The AMPLATZER Muscular VSD Occluder was approved by the US Food and Drug Administration (FDA) in September, 2007. This study is designed to further evaluate the safety and effectiveness in subjects implanted with the AMPLATZER Muscular VSD Occluder.

Detailed Summary:
Sponsor: St. Jude Medical

Current Primary Outcome: The primary safety objective is to evaluate the proportion of subjects experiencing a major adverse event within 12 months of the procedure. Subjects will be followed for 5 years post implant. [ Time Frame: 12 months ]

Original Primary Outcome: The primary safety objective is to evaluate the proportion of subjects experiencing a major adverse event within 12 months of the procedure. [ Time Frame: 12 months ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: St. Jude Medical

Dates:
Date Received: March 27, 2008
Date Started: March 2008
Date Completion: September 2023
Last Updated: December 14, 2016
Last Verified: December 2016