CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 92 enrolled
Drug / intervention
Muscular VSD Occluder device implantation (AMPLATZER Muscular VSD Occluder)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00647387
NCT00647387N/ACompleted
CompareCT.gov

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

Abbott Medical Devices·interventional·Posted Mar 31, 2008·Updated Feb 11, 2025

In Brief

A clinical study evaluating Muscular VSD Occluder device implantation (AMPLATZER Muscular VSD Occluder) for Ventricular Septal Defects. Completed, enrolled 92 participants across 51 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVentricular Septal Defects
CountriesCanada, United States
Collaborators--

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 31, 2008
Enrollment StartMar 1, 2008
Primary CompletionFeb 23, 2024
TodayJul 2, 2026
Enrollment to primary: 16.0 yearsPosted 18.3 years ago

Interventions

Muscular VSD Occluder device implantation (AMPLATZER Muscular VSD Occluder)device

Device