Status:
COMPLETED
Closure of Atrial Septal Defects With the AMPLATZER Septal Occluder - Post Approval Study
Lead Sponsor:
Abbott Medical Devices
Conditions:
Atrial Septal Defect
Eligibility:
All Genders
Phase:
NA
Brief 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
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT00650936
Start Date
August 1 2007
End Date
June 1 2014
Last Update
July 9 2019
Active Locations (51)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Kaiser Permanente
Los Angeles, California, United States, 90027
3
Children's Hospital of Central California
Madera, California, United States, 93636
4
Children's Hospital Oakland
Oakland, California, United States, 94609