Observational Study of the Lifetech CeraFlex PFO Closure System for Non-Surgical Patent Foramen Ovale Closure with 24-Month Follow-Up

What this Trial Is About

Researchers are collecting real-world data on patient outcomes to assess the success and performance of the Lifetech CeraFlex PFO Closure System, a device designed to close Patent Foramen Ovale PFO without surgery. This multicenter, prospective, observational study aims to provide valuable information on how well the device works in everyday medical practice. Participants will receive the CeraFlex PFO Closure System, which includes the CeraFlex PFO Occluder and the SteerEase Introducer. The study follows patients after the procedure, tracking their progress at discharge, and then at 1-3 months, 6 months, 12 months, and 24 months post-procedure. The enrollment period is expected to last about 18 months, with each participant followed for two years after device implantation. During the study, participants will undergo various assessments including monitoring for procedural success shortly after the procedure, checking for residual shunts at several follow-up points, and tracking stroke-related events, device deficiencies, serious adverse events, and deaths up to 24 months post-implantation. Data is collected electronically to ensure accurate tracking of patient outcomes over the entire study period.

CeraFlex PFO Closure System PMCF Study