Closure of Atrial Septal Defects with the Amplatzer Septal Occluder Post-Approval Study
Study Status
Open to Enrollment
Study Description
The purpose of this study is to prospectively evaluate the incidence of blood-flow compromise and to obtain long-term survival data on patients implanted with the Amplatzer Septal Occluder. The Amplatzer Septal Occluder is a self-expandable, double-disc device made from a nickel-titanium (nitinol) wire mesh. The two discs are linked together by a short connecting waist. The discs and waist have polyester fabric sewn into them. The polyester fabric is the same kind that is used by surgeons to close other heart devices.
Sponsor
AGA Medical Corporation
Key Eligibility
A subject will meet inclusion criteria if he/she: 1) is indicated for implantation with the Amplatzer Septal Occluder for occlusion of a secundum atrial septal defect 2) is willing and able to complete the follow0up requirements of this study, and 3) signs the informed consent (or a legal representative signs the informed consent).
Principal Investigator
Contact
- Dolores Reynolds, RN, BSN
- (212) 746-4617
- [email protected]
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Contact Us
For general inquiries, or if you need assistance finding a study, please contact:
Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]
