Asan Medical Center
Seoul, 05055, South Korea
Location status: Recruiting
NCT Number: NCT05238610
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
Interested in participating?
Request Info60 year and older
All sexes
Observational
Seoul, 05055, South Korea
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
PFO-closure will be performed after 3-6 month of observation and monitoring for paroxysmal atrial fibrillation
Time frame: at least 1 year
Time to occurrence of ischemic stroke after registration
Time frame: at least 1 year
Time to major cardiovascular event after registration
Time frame: at least 1 year
Time to hemorrhagic stroke after registration
Time frame: at least 1 year
Time to vascular death after registration
Time frame: at least 1 year
Time to myocardial infarction
Time frame: at least 1 year
Time to atrial fibrillation after registration
Time frame: at least 1 year
Time to atrial fibrillation lasting more than 2 or 6 min after registration
Time frame: at least 1 year
Time to major bleeding event after registration
Contact information is provided by the study sponsor or research team.
Bum Joon Kim, MD PhD
CONTACT
Sun U Kwon, MD. PhD
CONTACT
Asan Medical Center
Other
Prospective Registry of Elderly Patients With ESUS to Evaluate the Role of Covert Atrial Fibrillation and Patent Foramen Ovale
Acronym: COACH_ESUS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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