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

Cryptogenic Stroke Clinical Trial

— DefenseElderly  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04285918
• Other study ID #: 2019-1112
• Status: Recruiting
• Start date: October 2, 2019
• Est. completion date: October 2, 2024

Study information

• Verified date: February 2020
• Source: Asan Medical Center
• Contact: Jae-Kwan Song
• Phone: +82 2 3010 3155
• Email: jksong[@]amc.seoul.kr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

Description:

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: October 2, 2024
• Est. primary completion date: October 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Patients =60 y/o with ESUS and PFO that is likely to have causative role (high-risk anatomical feature) (cohort A)

• Patients =60 y/o with ESUS without PFO, or with non-high risk PFO (cohort B)

• The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the institutional review board

• Patients who are scheduled to have implantable cardiac monitoring

Exclusion Criteria:

• Transient ischemic attack

• Lacunar infarction (infarction at subcortical area with a lesion diameter less than 2cm on MR)

• Presence of complex aortic atheroma (=4mm in plaque thickness or presence of mobile components)

• Presence of =50% luminal stenosis (extra- or intracranial) in arteries supplying the ischemic area

• Unwillingness or inability to comply with the procedures described in this protocol

• Life expectancy < 1 years for any non-cardiac or cardiac causes

Related Conditions & MeSH terms

• Atrial Fibrillation
• Cryptogenic Stroke
• Foramen Ovale, Patent
• High Risk Patent Foramen Ovale
• Stroke

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Asan Medical Center	Medtronic

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Paroxysmal AF episodes > 30 seconds detected with intermittent recordings or = 2 minutes during ICM within 6 months	Paroxysmal AF episodes > 30 seconds detected with intermittent recordings or = 2 minutes during ICM within 6 months	Enrollment to 6 months
Secondary	Paroxysmal AF episodes > 30 seconds detected with intermittent recordings or = 2 minutes during ICM within 36 months	Paroxysmal AF episodes > 30 seconds detected with intermittent recordings or = 2 minutes during ICM within 36 months	Enrollment to 36 months
Secondary	Paroxysmal AF episodes > 30 seconds detected with intermittent recordings or = 6 minutes during ICM at 6 months and 36 months	Paroxysmal AF episodes > 30 seconds detected with intermittent recordings or = 6 minutes during ICM at 6 months and 36 months	6 months to 36 months
Secondary	Rates of percutaneous device closure, prescription of anticoagulants (warfarin or direct oral anticoagulants)	Rates of percutaneous device closure, prescription of anticoagulants (warfarin or direct oral anticoagulants)	Enrollment to 36 months
Secondary	Recurrent stroke or TIA	Recurrent stroke or TIA	Enrollment to 36 months
Secondary	All-cause death, Vascular Death	All-cause death, Vascular Death	Enrollment to 36 months