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CeraFlex PFO Closure System PMCF Study

NCT06120270 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 180

Last updated 2026-01-26

No results posted yet for this 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.

Conditions

  • Patent Foramen Ovale

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).

Sponsors & Collaborators

  • Lifetech Scientific (Shenzhen) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Marcus Sandri, Dr · German Heart Center Leipzig

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-03
Primary Completion
2026-12-31
Completion
2028-12-31

Countries

  • Germany
  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06120270 on ClinicalTrials.gov