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

This study is currently recruiting participants.

Verified by AGA Medical Corporation, January 2009

First Received: March 31, 2008 Last Updated: March 11, 2009 History of Changes

Sponsored by:	AGA Medical Corporation
Information provided by:	AGA Medical Corporation
ClinicalTrials.gov Identifier:	NCT00650936

Purpose

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

Condition	Intervention
Atrial Septal Defect	Device: AMPLATZER Septal Occluder

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Further study details as provided by AGA Medical Corporation:

Primary Outcome Measures:

The primary objective is to evaluate the risk of hemodynamic compromise in patients who receive the AMPLATZER Septal Occluder device. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The co-primary objective is to assess the safety and effectiveness of the AMPLATZER Septal Occluder device and delivery system. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1000
Study Start Date:	August 2007
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
I: Experimental	Device: AMPLATZER Septal Occluder AMPLATZER Septal Occluder

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00650936

Contacts

Contact: Lorry Witte

763-531-2739

Show 29 Study Locations

Sponsors and Collaborators

AGA Medical Corporation

More Information

No publications provided

Responsible Party:	AGA Medical Corporation ( Lorry Witte )
Study ID Numbers:	AGA-014
Study First Received:	March 31, 2008
Last Updated:	March 11, 2009
ClinicalTrials.gov Identifier:	NCT00650936 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by AGA Medical Corporation:

Atrial
Septal
Defect

Study placed in the following topic categories:

Heart Septal Defects
Heart Diseases
Cardiovascular Abnormalities
Congenital Heart Septum Defect

Congenital Abnormalities
Heart Defects, Congenital
Heart Septal Defects, Atrial

Additional relevant MeSH terms:

Heart Septal Defects
Heart Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases

Congenital Abnormalities
Heart Defects, Congenital
Heart Septal Defects, Atrial

ClinicalTrials.gov processed this record on May 07, 2009