Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
300 participants
INTERVENTIONAL
2014-11-30
2019-08-31
Brief Summary
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1. To analyze long term outcome of patients with acute stroke with atrial fibrillation according to the rhythm control
2. To analyze recurrence rate of atrial fibrillation or recurrence stroke in patients with acute stroke according to the rhythm control (by antiarrhythmic drug, cardioversion, catheter ablation)
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Rhythm control group
1. Start AAD right after evaluating for LA size, EF, LA thrombus, and presence of CAD during anticoagulation
2. Cardioversion after 1 month
3. Rhythm FU schedule (2012 ACC/AHA/ESC guidelines)
4. If AF recur, RFCA
Rhythm control
1. Start AAD right after evaluating for LA size, EF, LA thrombus, and presence of CAD during anticoagulation
2. Cardioversion after 1 month
3. Rhythm FU schedule (2012 ACC/AHA/ESC guidelines)
4. If AF recur, RFCA
Rate control group
1. No AAD, just anticoagulation
2. HR control between 60\~110bpm (with beta blocker, calcium channel blocker, digoxin)
3. Without the treatment about antiarrhythmia and rhythm control, deification of rate control, the subject will be drop out for study.
Rate control
1. No AAD, just anticoagulation
2. HR control between 60\~110bpm (with beta blocker, calcium channel blocker, digoxin)
3. Without the treatment about antiarrhythmia and rhythm control, deification of rate control, the subject will be drop out for study.
Interventions
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Rhythm control
1. Start AAD right after evaluating for LA size, EF, LA thrombus, and presence of CAD during anticoagulation
2. Cardioversion after 1 month
3. Rhythm FU schedule (2012 ACC/AHA/ESC guidelines)
4. If AF recur, RFCA
Rate control
1. No AAD, just anticoagulation
2. HR control between 60\~110bpm (with beta blocker, calcium channel blocker, digoxin)
3. Without the treatment about antiarrhythmia and rhythm control, deification of rate control, the subject will be drop out for study.
Eligibility Criteria
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Inclusion Criteria
2. patients with Acute stroke within 7 days
3. LA diameter \< 55mm
4. patients possible to anticoagulation and anti arrhythmic drug
5. NIHSS score ≤12
Exclusion Criteria
2. Large cerebral lesion or cerebellar lesion (more than 1/3 of MCA area and 1/2 of ACA area, 1/2 of PCA area, 1/2 of cerebellar area)
3. active internal bleeding
4. Impossible to anticoagulation or anti arrhythmic drug
5. Valvular AF (MA\> GII, Mechanical valve, Mitral valve replacement)
6. LV ejection fraction \< 30%
7. Structural cardiac disease
8. Catheter ablation history for AF, Cardiac surgery
9. Already prescribed anti arrhythmic drugs
10. With severe medical disease
11. Expected survival \< 1year
12. Severe alcoholics, drug addiction
14\. Contraindication to MRI 15. Pregnancy
19 Years
ALL
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Locations
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Severance Cardiovascular Hospital, Yonsei University Health System
Seoul, , South Korea
Countries
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Central Contacts
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Hui-Na Pak, MD
Role: CONTACT
Facility Contacts
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References
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Park J, Shim J, Lee JM, Park JK, Heo J, Chang Y, Song TJ, Kim DH, Lee HA, Yu HT, Kim TH, Uhm JS, Kim YD, Nam HS, Joung B, Lee MH, Heo JH, Pak HN; RAFAS Investigators*. Risks and Benefits of Early Rhythm Control in Patients With Acute Strokes and Atrial Fibrillation: A Multicenter, Prospective, Randomized Study (the RAFAS Trial). J Am Heart Assoc. 2022 Feb;11(3):e023391. doi: 10.1161/JAHA.121.023391. Epub 2022 Jan 19.
Other Identifiers
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4-2014-0728
Identifier Type: -
Identifier Source: org_study_id
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