Overview

This trial is active, not recruiting.

Condition atrial septal defect
Treatment amplatzer septal occluder
Sponsor AGA Medical Corporation
Start date August 2007
End date December 2014
Trial size 1000 participants
Trial identifier NCT00650936, AGA-014

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
amplatzer septal occluder
AMPLATZER Septal Occluder

Primary Outcomes

Measure
The primary objective is to evaluate the risk of hemodynamic compromise in patients who receive the AMPLATZER Septal Occluder device.
time frame: 24 months

Secondary Outcomes

Measure
The co-primary objective is to assess the safety and effectiveness of the AMPLATZER Septal Occluder device and delivery system.
time frame: 24 months

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Patients must meet all inclusion criteria. A patient meets inclusion criteria if he/she: - is indicated for implantation with the AMPLATZER Septal Occluder for occlusion of a secundum atrial septal defect (Note: This does not include the indication for closure of a fenestration following a fenestrated Fontan procedure), - is willing and able to complete the follow-up requirements of this study, and - signs the informed consent (or a legal representative signs the informed consent).

Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by AGA Medical Corporation.