Encore PFO Closure Device - The PerFOrm Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorEncore Medical Inc.
About this 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.
Eligibility criteria
Qualifiers
Diagnosis of PFO, defined as visualization of microbubbles per TEE in the left atrium within three cardiac cycles from the right atrial opacification demonstrating right-to-left shunting at rest and/or during Valsalva release
Cryptogenic stroke within the last 270 days; stroke is defined as acute focal neurological deficit, presumed to be due to focal ischemia, and confirmed by MRI or CT to be a new, neuroanatomically relevant cerebral infarct
Disqualifiers
Age <18 years and age >60 years
Greater than 50% lumen diameter stenosis of intracranial or extracranial vessels
Intracardiac thrombus or tumor
Acute or recent (within 6 months) myocardial infarction (MI) or unstable angina
Trial design
Treatments tested in this trial
- Encore PFO closure device
- FDA-approved PFO closure device
Treatment groups
500 Participants
are divided into 2 treatment groupsSponsors and collaborators
Encore Medical Inc.
Lead sponsor
Bright Research Partners
Collaborator
Yale Cardiovascular Research Group
Collaborator
Source ClinicalTrials.gov