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Post Market Clinical Follow-up Study of IrisFITTM PFO (Patent Foramen Ovale) Occluder

NCT02882815 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2018-08-09

No results posted yet for this study

Summary

The purpose of the study is to collect more data about performance and safety of the device called "IrisFITTM PFO occluder". This data will be used to help more patients who will accept treatment with this device in the future.

Patients will undergo routine examination, procedure and follow-up. Related data will be collected and kept in a way that patient info is well protected.

Conditions

  • Patent Foramen Ovale

Interventions

DEVICE

IrisFIT PFO Occluder

Sponsors & Collaborators

  • Lifetech Scientific (Shenzhen) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • HORST SIEVERT · CARDIOVÄSCULARES CENTRUM FRANKFURT GERMANY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2015-11-30
Completion
2017-01-31

Countries

  • Germany
  • Ireland

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 NCT02882815 on ClinicalTrials.gov