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Prospective Registry of Elderly ESUS With PFO — COACH_ESUS  

Embolic Stroke of Undetermined Source Clinical Trial

Official title:
Prospective Registry of Elderly Patients With ESUS to Evaluate the Role of Covert Atrial Fibrillation and Patent Foramen Ovale

Clinical Trial Summary

Patent foramen ovale (PFO) is associated with an increased risk of stroke. PFO-closure was effective in preventing stroke in young stroke patients less than age 60 presented as an embolic stroke of undetermined source (ESUS). However, the benefit of PFO-closure in elderly ESUS patients is not clear. The investigators designed this prospective register-based observational study to verify the efficacy of PFO-closure in elderly ESUS patients with high-risk PFO, older than 60 years

Clinical Trial Description

The COACH-ELDERLY ESUS study is a multicenter, prospective, registry-based, observational study in elderly ESUS patients with high-risk PFO treated with PFO-closure + standard antiplatelet treatment or standard antiplatelet treatment only in 20 centers in Korea. Patients will receive an insertable loop recorder (ILR) to monitor paroxysmal atrial fibrillation. In cases, which are unavailable for ILR, recurrent EKG or Holter monitoring will be done based on the clinician's decision. Based on the attending physicians' decision with a multi-disciplinary approach, patients will receive PFO-closure with standard antiplatelet treatment or standard antiplatelet treatment only. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05238610
Study type Observational [Patient Registry]
Source Asan Medical Center
Contact Sun U Kwon, MD. PhD
Phone 82-2-3010-3960
Email sukwon@amc.seoul.kr
Status Recruiting
Phase
Start date January 17, 2022
Completion date May 31, 2027
View Details
See also
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