clinical trial · NCT05537753
Encore PFO Closure Device - The PerFOrm Trial
Patent Foramen OvaleCryptogenic StrokeEncore PFO closure deviceFDA-approved PFO closure device
brief 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.
started
Jul 12, 2023
primary completion
Apr 1, 2026
completion
Oct 1, 2030
last updated
Sep 19, 2024
detailed 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.
official title
Encore PFO Closure Device U.S. IDE Randomized Trial - The PerFOrm Trial
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol