CeraFlex PFO Closure System PMCF Study
ConditionPatent Foramen Ovale
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorLifetech Scientific (Shenzhen) Co., Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Confirmed PFO by medical examinations;
Associated with recurrent migraine/headache or TIA or cryptogenic stroke.
Measure the distance from the defect to the aorta root;
Measure the distance from the defect to the superior vena cava (SVC) rim; select a device with the radius of the right disc that will not exceed the lesser of these two distances.
Disqualifiers
Age <18 years or Age >85 years.
Patient with a history of ongoing Atrial Fibrillation (AF).
Patient with malignancy or other illness where life expectancy is less than 1 year.
Patient not covered by a social security scheme.
Trial population
Patients with PFO and need non-surgical closure of PFO.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
CeraFlex PFO Closure System
DeviceThe Lifetech CeraFlex™ PFO occluder device is a percutaneous, transcatheter closure device for the non-surgical closure of Patent Foramen Ovale (PFO).
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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 firstSecondary outcomes
1
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-implantation2
Rate of stroke related events
Ischemic stroke, cryptogenic stroke, or TIA
Time frame
From attempted procedure up to 24 months post-implantation3
Rate of Device Deficiencies
Including device malfunctions, failures, and non-conformances
Time frame
From attempted procedure up to 24 months post-implantation4
Incidence of Serious Adverse Event
SAE
Time frame
From attempted procedure up to 24 months post-implantationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov