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Evaluation of Prevalence and Clinical Impact of Atrial Fibrillation in Elderly Patients With Cryptogenic Stroke and High-Risk Patent Foramen Ovale

NCT04285918 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2020-02-26

No results posted yet for this study

Summary

The purpose of DEFENSE-ELDERLY is to identify the prevalence of AF and evaluate the clinical impact of AF in elderly ESUS patients and no other known sources of stroke besides a high-risk patent foramen ovale, and compare it with elderly ESUS patients without high-risk PFO (no PFO or non-high risk PFOs)

Conditions

  • Cryptogenic Stroke
  • High Risk Patent Foramen Ovale

Interventions

PROCEDURE

Percutaneous device closure

If there is no relevant AF detected for 6 months during intermittent follow-up or ICM, device closure of PFO is recommended for high-risk PFOs but is decided ultimately at the discretion of the attending physician. If there is any relevant AF identified from ICM or other modalities during follow-up, adequate secondary prevention with anticoagulants should be carried out. All this process and decision making should be a part of routine clinical practice.

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Asan Medical Center

    lead OTHER

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-02
Primary Completion
2024-10-02
Completion
2024-10-02

Countries

  • South Korea

Study Locations

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Entities

Companies

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 NCT04285918 on ClinicalTrials.gov