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Clinical Trial Summary

The objective of this study is to establish reasonable assurance of safety, effectiveness, and noninferiority of the Encore PFO closure device when compared to any investigator chosen FDA-approved PFO closure device.


Clinical Trial Description

This is a prospective, multicenter, randomized clinical study to determine the safety and effectiveness of the Encore PFO closure device, which is indicated for percutaneous, transcatheter closure of a patent foramen ovale (PFO) in patients who have had a cryptogenic stroke due to a presumed paradoxical embolism. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05537753
Study type Interventional
Source Encore Medical Inc.
Contact Mike Corcoran
Phone 651-797-0913
Email mcorcoran@encore-medical.com
Status Recruiting
Phase N/A
Start date July 12, 2023
Completion date October 2029

See also
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Active, not recruiting NCT04738071 - International Multicenter Patent foRamen OVale & strokE (IMPROVE) Registry
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