None listed
Conditions
Interventions
Procedure/Surgery : - Randomization is carried out through an internet-based randomization system, available 24 hours per day, 7 days per week, 365 days per year
- All procedures will be performed via
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - Patients refusing participation in the registry - Age 80 years old - Paroxysmal AF which lasting 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Freedom from documented atrial arrhythmia episodes lasting > 30 seconds without antiarrhythmics medications (after 3 months of blanking period) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Atrial arrhythmia recurrence during blanking period (3 months) after one or two procedures with/without antiarrhythmic medications - Atrial tachycardia or flutter recurrence during long-term follow-up ) after one or two procedures with/without antiarrhythmic medications - Atrial fibrillation recurrence during long-term follow-up) after one or two procedures with/without antiarrhythmic medications - Incidence of peri-procedural complications (including stroke, cardiac tamponade, esophageal injury, phrenic nerve damage, and death) - Rate of first-pass isolation or first-freeze isolation (%) - Procedure duration (minutes) - Ablation time (minutes) - Fluoroscopy time (minutes) - Procedure time (minutes, skin to skin) - LA dwelling time - Ablation time (seconds) - Quality of life changes at 12 months compared to baseline - Number of repeat procedures - AF burden at 12 months after ablation assessed by 2-week patch monitoring - LA pressure, mmHg (max/min/mean) after septal puncture and after procedure - Role of 2-week patch electrode in the detection of post-procedure atrial tachyarrhythmia in comparison to conventional Holter monitoring | — |
Countries
Korea, Republic of
Contacts
Public ContactMinsoo Cho
Asan Medical Center
Outcome results
None listed