CeraFlex PFO Closure System PMCF Study

Official title

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

Overview

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.

Detailed 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.

Interventions

• 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).

Primary outcome measures

• Procedural success rate [Time frame: Procedure/at discharge or 7 days post-procedure, whichever comes first]

Secondary outcome measures (5)

• Residual shunt [Time frame: At procedure, 6 months and 12 months post-implantation]
• Rate of stroke related events [Time frame: From attempted procedure up to 24 months post-implantation]
• Rate of Device Deficiencies [Time frame: From attempted procedure up to 24 months post-implantation]
• Incidence of Serious Adverse Event [Time frame: From attempted procedure up to 24 months post-implantation]
• Incidence of death [Time frame: From attempted procedure up to 24 months post-implantation]

Eligibility criteria

Inclusion criteria

• Patient with indication(s) for PFO Occluder Closure in the Instruction For Use (IFU):

• Confirmed PFO by medical examinations;
• Associated with recurrent migraine/headache or TIA or cryptogenic stroke.
• Patient characteristics consistent with the corresponding IFU \& Device Size Selection:

• 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.
• Patients who are willing to comply with all study procedures and be available for the duration of the study.
• Patients or legally authorized representative(s) who are willing and capable of providing informed consent.

Exclusion criteria

• 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.
• Patients who are participating in an investigational drug or device study currently.
• Women of childbearing potential who are, or plan to become pregnant during the time of the study (method of assessment upon physician's discretion).
• Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
• Any contraindication mentioned in the corresponding IFU：

• 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.
• 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.
• Patients whose heart or vein size is too small to allow TEE probing or catheterization.
• Patients who are in the condition, e.g. active infection, which would cause them to be poor candidates for cardiac catheterization.
• Patients known to have sepsis within one month prior to implantation, or any systemic infection that cannot be successfully treated prior to device placement.
• Patients whose heart does not have enough tissue to secure the device.
• Patients with hypercoagulation disease.
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Germany · 10 centers

• Kardiologisch-Angiologische Praxis - Herzzentrum Bremen — Bremen
• Heart Center Dresden — Dresden
• Hospital Fürth — Fürth
• Kath. Marienkrankenhaus gGmbH — Hamburg
• Universitätsklinikum Hamburg-Eppendorf (UKE) — Hamburg
• German Heart Center Leipzig — Leipzig
• Klinikum St. Georg gGmbH Leipzig — Leipzig
• German Heart Center Munich — Munich
• … and 2 more centers

South Korea · 5 centers

• Chonnam National University Hospital — Gwangju
• Yeungnam University Medical Center — Daegu
• ASAN Medical Center — Seoul
• Samsung Medical Center — Seoul
• Catholic University of Korea St. Vincent's Hospital — Suwon

Identifiers

NCT: NCT06120270 · LT/TS/276I-2023-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗