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Clinical Trials in Germany / NCT06120270
Recruiting Observational

CeraFlex PFO Closure System PMCF Study

NCT06120270 · tracked via the Priya Life Science Germany tracker
Phase
Observational
Started
2023-11-03
Last updated
2026-06-10

Condition(s) studied

Patent Foramen Ovale

Investigational drug(s) / intervention(s)

CeraFlex PFO Closure System

CeraFlex PFO Closure System: The Lifetech CeraFlex™ PFO occluder device is a percutaneous, transcatheter closure device for the non-surgical closure of Patent Foramen Ovale (PFO).

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria: 1. Patient with indication(s) for PFO Occluder Closure in the Instruction For Use (IFU): 1. Confirmed PFO by medical examinations; 2. Associated with recurrent migraine/headache or TIA or cryptogenic stroke. 2. Patient characteristics consistent with the corresponding IFU \& Device Size Selection: 1. Measure the distance from the defect to the aorta root; 2. 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. 3. Patients who are willing to comply with all study procedures and be available for the duration of the study. 4. Patients or legally authorized representative(s) who are willing and capable of providing informed consent. Exclusion Criteria: 1. Age \<18 years or Age \>85 years. 2. Patient with a history of ongoing Atrial Fibrillation (AF). 3. Patient with malignancy or other illness where life expectancy is less than 1 year. 4. Patient not covered by a social security scheme. 5. Patients who are participating in an investigational drug or device study currently. 6. Women of childbearing potential who are, or plan to become pregnant during the time of the study (method of assessment upon physician's discretion). 7. Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study. 8. Any contraindication mentioned in the corresponding IFU: 1. Patients known to have intracardiac thrombi, especially left atrial or left atrial appendage thrombi, demonstrated by echocardiography. Patients known to have a bleeding disorder, untreated ulcer, or any other contraindications to aspirin therapy unless another anti-platelet agent can be administered for 6 months. 2. Anatomy in which the CeraFlexTM PFO device of the required size would interfere with intra-cardiac structure or intra-vascular structure, such as a pulmonary vein, or aorta root. 3. Patients whose heart or vein size is too small to allow TEE probing or catheterization. 4. Patients who are in the condition, e.g. active infection, which would cause them to be poor candidates for cardiac catheterization. 5. Patients known to have sepsis within one month prior to implantation, or any systemic infection that cannot be successfully treated prior to device placement. 6. Patients whose heart does not have enough tissue to secure the device. 7. Patients with hypercoagulation disease. 8. Any patient for whom the radius of the device is greater than the distance from the patent foramen ovale to the aortic root or superior vena cava. * No contraindications specified in the SteerEase introducer IFU.

Primary outcome measure(s)

Trial sites (15)

FacilityCityRegionStatus
Kardiologisch-Angiologische Praxis - Herzzentrum Bremen Bremen Germany Recruiting
Heart Center Dresden Dresden Germany Not Yet Recruiting
Hospital Fürth Fürth Germany Recruiting
Kath. Marienkrankenhaus gGmbH Hamburg Germany Recruiting
Universitätsklinikum Hamburg-Eppendorf (UKE) Hamburg Germany Recruiting
German Heart Center Leipzig Leipzig Germany Recruiting
Klinikum St. Georg gGmbH Leipzig Leipzig Germany Not Yet Recruiting
German Heart Center Munich Munich Germany Recruiting
Herzzentrum Trier Trier Germany Recruiting
University clinic Tübingen Tübingen Germany Recruiting
Chonnam National University Hospital Gwangju Gwangju Recruiting
Yeungnam University Medical Center Daegu South Korea Recruiting
ASAN Medical Center Seoul South Korea Recruiting
Samsung Medical Center Seoul South Korea Recruiting
Catholic University of Korea St. Vincent's Hospital Suwon South Korea Recruiting

More Lifetech Scientific (Shenzhen) Co., Ltd. trials in Germany

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06120270 on ClinicalTrials.gov ↗ ← All trials in Germany