Encore PFO Closure Device U.S. IDE Randomized Trial - The PerFOrm Trial
Encore Medical Inc.
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.
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.
Eligibility
- Age range
- 18–60 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. 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 2. 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 Exclusion Criteria: 1. Age \<18 years and age \>60 years 2. Greater than 50% lumen diameter stenosis of intracranial or ext…
Interventions
- DeviceEncore PFO closure device
The Encore PFO closure device comprises an implant component and a single-use delivery system.
- DeviceFDA-approved PFO closure device
Chosen by the investigator
Locations (8)
- Arkansas CardiologyLittle Rock, Arkansas
- Southern CA Permanente Medical Group - Kaiser San Diego and Scripps Memorial HospitalLa Jolla, California
- University of South FloridaTampa, Florida
- Mercy One Iowa Heart CenterWest Des Moines, Iowa
- Kansas University Medical CenterKansas City, Kansas
- Jackson Heart ClinicJackson, Mississippi