Status: Recruiting
Encore PFO Closure Device - The PerFOrm Trial
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.
Participants needed: 500
Trial details
Age: 18-60Biological sex: AllType: InterventionalSponsor: Encore Medical Inc.Updated: Sep 19, 2024Locations: 8
Eligibility criteria
Diagnosis of PFO, defined as visualization of microbubbles per TEE in the left a... [+1]
Age <18 years and age >60 years [+29]