Comparison of extended cryoballoon ablation, standard cryoballoon ablation, and radiofrequency catheter ablation in patients with persistent atrial fibrillation: A Multicenter, randomized controlled, clinical trial
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0005933
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 288
Patients with age between 18-80 years
AND
- Patients with persistent (=7 days) AF documented on 12-lead ECG or Holter monitoring.
AND
- AF refractory/intolerant to class I or III antriarrhytmic drug
AND
- Able and willing to provide written informed consent to CRYO or RFCA and participation in this investigation
- Patients refusing participation in the registry
- Age< 18 years old or > 80 years old
- Paroxysmal AF which lasting < 7 days
- Mitral stenosis or mechanical prosthetic valve
- Patients with left atrial size = 55 mm (2D echocardiography, Anterior-posterior diameter in parasternal long axis view)
- Anatomy of pulmonary vein was not suitable for CB or CB+, including common ostium or ostium size > 26mm
- Pregnant woman of child-bearing age with a positive pregnancy test before treatment
- Presence of atrial septal defect or patent foramen ovale closure device
- Presence of intracardiac thrombus
- Contraindications to the systemic anticoagulation
- NYHA functional class IV heart failure
- Prior catheter or surgical ablation of AF
- Acute coronary syndrome within 3 months
- Planned open heart surgery within 3 months
- Prior open-heart surgery within 3 months
- End stage renal disease or chronic kidney disease (estimated glomerular filtration rate [MDRD method] < 30mL/min/1.73m)
- Life expectancy less than 1 year
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Freedom from documented atrial arrhythmia episodes lasting > 30 seconds without antiarrhythmics medications (after 3 months of blanking period)
- Secondary Outcome Measures
Name Time Method