Last updated on February 2019

AMPLATZER PFO Occluder Post Approval Study

Brief description of study

The purpose of this single arm, multi-center study is to confirm the safety and effectiveness of the AMPLATZER PFO Occluder in the post Approval Setting.

Detailed Study Description

A maximum of 1214 adult subjects will be enrolled at up to 100 centers in the U.S. and Canada. Subjects will have follow-up at 1 month, 6 months, 12 months and annually thereafter through 5 years post implant.

Clinical Study Identifier: NCT03309332

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Ochsner Medical Center

New Orleans, LA United States
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