Encore PFO Closure Device U.S. IDE Randomized Trial - The PerFOrm Trial
Status: Recruiting
Location: See all (8) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:
• 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
Locations
United States
Arkansas
Arkansas Cardiology
RECRUITING
Little Rock
California
Southern CA Permanente Medical Group - Kaiser San Diego and Scripps Memorial Hospital
RECRUITING
La Jolla
Florida
University of South Florida
RECRUITING
Tampa
Iowa
Mercy One Iowa Heart Center
RECRUITING
West Des Moines
Kansas
Kansas University Medical Center
RECRUITING
Kansas City
Mississippi
Jackson Heart Clinic
RECRUITING
Jackson
Nebraska
CHI Health
RECRUITING
Omaha
South Carolina
Medical University of South Carolina Gazes Research Institute
RECRUITING
Charleston
Contact Information
Primary
Joseph Marino
jmarino@encore-medical.com
651-797-0913
Backup
Hannah Bearinger
hannah.bearinger@brightresearch.com
Time Frame
Start Date: 2023-07-12
Estimated Completion Date: 2030-10
Participants
Target number of participants: 500
Treatments
Experimental: Encore PFO closure device
Active_comparator: Any FDA-approved PFO closure device chosen by the investigator
Related Therapeutic Areas
Sponsors
Collaborators: Yale Cardiovascular Research Group, Bright Research Partners
Leads: Encore Medical Inc.