Endocardial catheter ablation versus thoracoscopic ablation in de novo persistent atrial fibrillation patients with enlarged left atrium : A Randomized Controlled Trial
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0009360
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 194
1. 19 years of age or older
2. Patients with persistent atrial fibrillation who have failed antiarrhythmic treatment or are unable to maintain antiarrhythmic drugs
3. European Heart Rhythm Association score for AF(EHRA) = 2
4. A person who is deemed appropriate to treat atrial fibrillation rhythm control through percutaneous catheter resection or thoracoscopic resection (prescribed by the investigator as medical judgment)
5. Patients with left atrial hypertrophy (LA diameter = 50 mm or LAVI = 45 ml/?)
1. Patients who have undergone percutaneous catheter resection or thoracoscopic resection for past atrial fibrillation
2. a patient who has had past chest or heart surgery
3. If there is an absolute contraindication to anticoagulant therapy
4. A person whose life expectancy is less than one year due to a non-heart disease or who is expected to be less compliant with treatment (as determined by the investigator by medical judgment)
5. a patient who refused to participate in the study
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method First recurrence of atrial tachyarrhythmia
- Secondary Outcome Measures
Name Time Method First recurrence of atrial fibrillation, First recurrence of atrial flutter, First recurrence of atrial tachycardia, All-cause and cardiac death, Stroke, Hospitalization for heart failure, Bleeding, % Burden of atrial tachyarrhythmia or atrial fibrillation, Detection rate of atrial tachyarrhythmia in 14-day patch holter and 24-hour holter at 3-month, 6-month, and 12-month after the index procedure, Echocardiographic parameters, NT proBNP, procedure related outcomes, Adverse Event, Patients' quality of life