CeraFlex PFO Closure System PMCF Study

Patent Foramen Ovale Clinical Trial

Official title:

CeraFlex PFO Closure System Post-Market Clinical Follow-up Study: A Multi-center, Prospective, Observational, Post-market Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06120270
• Other study ID #: LT/TS/276I-2023-01
• Status: Recruiting
• Start date: November 3, 2023
• Est. completion date: July 2027

Study information

• Verified date: April 2024
• Source: Lifetech Scientific (Shenzhen) Co., Ltd.
• Contact: KaDirr Shemsi, PM
• Phone: 17621309203
• Email: KaDirr[@]lifetechmed.com
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: July 2027
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Foramen Ovale, Patent
• Patent Foramen Ovale

Intervention

Device:
• 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).

Locations

Country	Name	City	State
Germany	Kardiologisch-Angiologische Praxis - Herzzentrum Bremen	Bremen
Germany	Heart Center Dresden	Dresden
Germany	Hospital Fürth	Fürth
Germany	Kath. Marienkrankenhaus gGmbH	Hamburg
Germany	German Heart Center Leipzig	Leipzig
Germany	Klinikum St. Georg gGmbH Leipzig	Leipzig
Germany	German Heart Center Munich	Munich
Germany	University clinic Tübingen	Tübingen

Sponsors (1)

Lead Sponsor	Collaborator
Lifetech Scientific (Shenzhen) Co., Ltd.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedural success rate	Procedure success is defined as a composite of : 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; successful implantation of the device at the procedure.	Procedure/at discharge or 7 days post-procedure, whichever comes first
Secondary	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.	At procedure, 6 months and 12 months post-implantation
Secondary	Rate of stroke related events	Ischemic stroke, cryptogenic stroke, or TIA	From attempted procedure up to 24 months post-implantation
Secondary	Rate of Device Deficiencies	Including device malfunctions, failures, and non-conformances	From attempted procedure up to 24 months post-implantation
Secondary	Incidence of Serious Adverse Event	SAE	From attempted procedure up to 24 months post-implantation
Secondary	Incidence of death	Death	From attempted procedure up to 24 months post-implantation