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Treatment of tachycardia-bradycardia syndrome using radiofrequency catheter ablation of paroxysmal atrial fibrillation versus permanent pacemaker implantation: prospective, randomized trial

Not Applicable
Recruiting
Conditions
Diseases of the circulatory system
Registration Number
KCT0000155
Lead Sponsor
Asan Medical Center
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
88
Inclusion Criteria

1. Documented prolonged sinus pauses on termination of AF ranging from 3 to 9 seconds
2. Symptoms of syncope or presyncope
3. Informed consent

Exclusion Criteria

1. Left ventricular ejection fraction < 40%
2. prior history of ablation of atrial fibrillation
3. thrombi in Left atrium or Left atrial appendage
4. New York Heart Association class III or IV
5. prior acute myocardial infarction or coronary artery bypass grafting within 6 months
6. prior percutaneous coronary intervention within 1 year
7. Severe valvular disease
8. Life expectancy of less than one year
9. Contraindication of anticoagulants
10. Pregnant women or women planning pregnancy(The urine hCG test is usually performed in women of reproductive age)

Study & Design

Study Type
Interventional Study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
all-cause hospitalization and syncope
Secondary Outcome Measures
NameTimeMethod
all-cause death;atrial fibrillation burden by 24-hour ambulatory ECG monitoring;Minimum heart rate, Maximum pause, number of sinus pause > 3 seconds by 24-hour ambulatory ECG monitoring;LA size on transthoracic echocardiography ;treadmil test
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