Treatment of tachycardia-bradycardia syndrome using radiofrequency catheter ablation of paroxysmal atrial fibrillation versus permanent pacemaker implantation: prospective, randomized trial
- 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
1. Documented prolonged sinus pauses on termination of AF ranging from 3 to 9 seconds
2. Symptoms of syncope or presyncope
3. Informed consent
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
Name Time Method all-cause hospitalization and syncope
- Secondary Outcome Measures
Name Time Method 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