CeraFlex PFO Closure System PMCF Study

Status Recruiting

Clinical Trial Summary

The purpose of this study is to compile real-world data on patient outcomes and evaluate the procedural success and performance of the CeraFlex™ PFO Closure System.

Clinical Trial Description

This is a multicenter, prospective, observational, single-arm, open-label, post-market Study. The study device is the Lifetech CeraFlex PFO closure system, which is composed of a) CeraFlex PFO Occluder, and b) SteerEase Introducer. The PFO Closure System is indicated for the non-surgical closure of Patent Foramen Ovale (PFO), and the study objective is to collect real-world data on patient outcomes and evaluate the procedural success and performance of the CeraFlex PFO Closure System. The estimated enrollment period is approximately 18 months, and each subject will followed 24 months post-procedure. The assessment schedule at discharge, 1-3 months follow-up, 6 months follow-up, 12 months follow-up, and 24 months follow-up. Electronic Date Capture (EDC) System will be used for this Study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06120270
Study type	Observational
Source	Lifetech Scientific (Shenzhen) Co., Ltd.
Contact	KaDirr Shemsi, PM
Phone	17621309203
Email	KaDirr@lifetechmed.com
Status	Recruiting
Phase
Start date	November 3, 2023
Completion date	July 2027

View Details

See also
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