RecruitingNCT06120270

CeraFlex PFO Closure System PMCF Study

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

Sponsor

Lifetech Scientific (Shenzhen) Co., Ltd.

Enrollment

180 participants

Start Date

Nov 3, 2023

Study Type

OBSERVATIONAL

Conditions

Patent foramen ovale

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

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called CeraFlex PFO Closure System for people with patent foramen ovale. The study is currently recruiting participants at 15 locations. People eligible for this study include aged 18 Years to 85 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECeraFlex 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(15)

Kardiologisch-Angiologische Praxis - Herzzentrum Bremen

Bremen, Germany

Heart Center Dresden

Dresden, Germany

Hospital Fürth

Fürth, Germany

Kath. Marienkrankenhaus gGmbH

Hamburg, Germany

Universitätsklinikum Hamburg-Eppendorf (UKE)

Hamburg, Germany

German Heart Center Leipzig

Leipzig, Germany

Klinikum St. Georg gGmbH Leipzig

Leipzig, Germany

German Heart Center Munich

Munich, Germany

Herzzentrum Trier

Trier, Germany

University clinic Tübingen

Tübingen, Germany

Chonnam National University Hospital

Gwangju, Gwangju, South Korea

Yeungnam University Medical Center

Daegu, South Korea

ASAN Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Catholic University of Korea St. Vincent's Hospital

Suwon, South Korea

View Full Details on ClinicalTrials.gov

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NCT06120270

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