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.
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 Type
OBSERVATIONAL
Enrollment
180
The Lifetech CeraFlex™ PFO occluder device is a percutaneous, transcatheter closure device for the non-surgical closure of Patent Foramen Ovale (PFO).
Kardiologisch-Angiologische Praxis - Herzzentrum Bremen
Bremen, Germany
RECRUITINGHeart Center Dresden
Dresden, Germany
Procedural success rate
Procedure success is defined as a composite of : 1. absence of peri-procedural stroke-related events (ischemic stroke, cryptogenic stroke, or TIA), device embolization, cardiac or vascular perforation, or death, at discharge or 7 days post-procedure, whichever comes first; 2. successful implantation of the device at the procedure.
Time frame: Procedure/at discharge or 7 days post-procedure, whichever comes first
Residual shunt
Residual shunt was classified on the basis of the estimated number of microbubbles detected in the left atrium within three cardiac cycles after appearance in the right atrium, as observed on cTTE/cTEE while the patient was at rest or during Valsalva procedure. The presence of 0 microbubbles was classified as no shunt, 1 to 5 microbubbles as small, 6 to 25 microbubbles as moderate, and more than 25 microbubbles as large.
Time frame: At procedure, 6 months and 12 months post-implantation
Rate of stroke related events
Ischemic stroke, cryptogenic stroke, or TIA
Time frame: From attempted procedure up to 24 months post-implantation
Rate of Device Deficiencies
Including device malfunctions, failures, and non-conformances
Time frame: From attempted procedure up to 24 months post-implantation
Incidence of Serious Adverse Event
SAE
Time frame: From attempted procedure up to 24 months post-implantation
Incidence of death
Death
Time frame: From attempted procedure up to 24 months post-implantation
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Hospital Fürth
Fürth, Germany
RECRUITINGKath. Marienkrankenhaus gGmbH
Hamburg, Germany
RECRUITINGUniversitätsklinikum Hamburg-Eppendorf (UKE)
Hamburg, Germany
RECRUITINGGerman Heart Center Leipzig
Leipzig, Germany
RECRUITINGKlinikum St. Georg gGmbH Leipzig
Leipzig, Germany
NOT_YET_RECRUITINGGerman Heart Center Munich
Munich, Germany
RECRUITINGHerzzentrum Trier
Trier, Germany
RECRUITINGUniversity clinic Tübingen
Tübingen, Germany
RECRUITING...and 5 more locations