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Closure of Atrial Septal Defects with the Amplatzer Septal Occluder Post-Approval Study

Clinical Trial Details

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.

Key eligibility:

  • indicated for implantation with the Amplatzer Septal Occluder for occlusion of a secundum atrial septal defect
  • willing and able to complete the follow0up requirements of this study
  • signs the informed consent (or a legal representative signs the informed consent)
  • Detailed eligiblity reviewed when you contact the study team

Study contact by location

Upper East Side - Manhattan

Contact(s)

Dolores T. Reynolds, RN, BSN
(212) 746-4617
dtr2001@med.cornell.edu

Primary Investigator(s)

Weill Cornell Medicine IRB #:

Status

Open to Enrollment