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By physician referral or invitation only

AMPLATZER Post Approval Study Registry

The Food and Drug Association (FDA) issued a Humanitarian Device Exemption (HDE) approval order for the AMPLATZERTM PIVSD Occluder on January 10, 2017. The Conditions of Approval require that St. Jude Medical (SJM) conduct a post approval study to evaluate the safety and probable benefit of the AMPLATZERTM PIVSD Occluder.

Age & Gender

  • 18 years ~ 99 years
  • Male, Female

Contact the Team

Location

Thank you for your interest, but this study is recruiting by invitation only.

North Carolina (Statewide)

Additional Study Information

Principal Investigator

John Vavalle
Medicine - Cardiology

Study Type

Clinical or Medical
Registry

Study Topics

Heart and Circulation

IRB Number

17-2793

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