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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

St. Jude Medical

ClinicalTrials.gov Identifier:

NCT00650936

First received: March 31, 2008

Last updated: January 30, 2015

Last verified: January 2015

History of Changes

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


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment

Further study details as provided by St. Jude Medical:

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:	June 2015
Estimated Primary Completion Date:	June 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: I	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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Show 51 Study Locations

Sponsors and Collaborators

St. Jude Medical

More Information

No publications provided


Responsible Party:	St. Jude Medical
ClinicalTrials.gov Identifier:	NCT00650936 History of Changes
Other Study ID Numbers:	AGA-014
Study First Received:	March 31, 2008
Last Updated:	January 30, 2015
Health Authority:	United States: Institutional Review Board

Keywords provided by St. Jude Medical:


Atrial Septal Defect

Additional relevant MeSH terms:


Heart Septal Defects Heart Septal Defects, Atrial Cardiovascular Abnormalities Cardiovascular Diseases	Congenital Abnormalities Heart Defects, Congenital Heart Diseases

ClinicalTrials.gov processed this record on March 02, 2015

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