Atrial Fibrillation, Persistent
Conditions
Brief summary
The objective of this study is to test the efficacy hypothesis that extended cryoballoon ablation is superior to either standard cryoballoon ablation or radiofrequency ablation
Detailed description
The posterior wall of the left atrium is known to contribute to arrhythmogenicity and has been associated with higher rates of atrial fibrillation (AF) recurrence. In this trial, we aim to evaluate whether extended cryoballoon ablation-comprising pulmonary vein isolation (PVI) plus posterior wall isolation-results in superior rhythm outcomes compared to standard cryoballoon ablation (PVI only) or radiofrequency ablation (PVI only). Patients will be randomly assigned to one of three treatment arms: extended cryoballoon ablation, standard cryoballoon ablation, or radiofrequency ablation. Each patient will receive the assigned treatment accordingly. The primary outcome is the incidence of atrial tachyarrhythmias-including atrial fibrillation, atrial flutter, and atrial tachycardia-lasting more than 30 seconds, occurring after discontinuation of antiarrhythmic drugs and following a 3-month post-procedure blanking period. Outcomes will be compared at 1 year after the procedure.
Interventions
PROCEDURERadiofrequency ablation
Radiofrequency ablation of pulmonary veins
PROCEDUREExtended cryoballoon ablation
Cryoablation of pulmonary veins + posterior wall isolation
PROCEDUREStandard cryoballoon ablation
Standard cryoablation of pulmonary veins
Sponsors
Asan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged between 18-80 years * Patients with persistent (≥7 days) AF documented on 12-lead ECG or Holter monitoring. * AF refractory/intolerant to class I or III antiarrhythmic drugs * Able and willing to provide written informed consent to CB or RF ablation and participation in this investigation
Exclusion criteria
* Age \<18 years old or \>80 years old * Paroxysmal AF lasting \<7 days * Mitral stenosis or mechanical prosthetic valve * Patients with left atrial size ≥ 50 mm (2D echocardiography, Anterior-posterior diameter in parasternal long axis view) * Anatomy of pulmonary vein not suitable for standard CB or extended CB, including common ostium or ostium size \> 26mm * Pregnant woman of childbearing 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/1.73m²) * Life expectancy less than 1 year.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the incidence rates of atrial tachyarrhythmias | 3-month blanking period post-procedure | Incidence of atrial tachyarrhythmias (including atrial fibrillation, flutter, or tachycardia) lasting \>30 seconds after discontinuation of antiarrhythmic therapy, assessed following a 3-month blanking period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AF burden by 2-week patch monitoring | 1 year | AF burden assessed at 12 months after ablation |
| Atrial arrhythmia recurrence during blanking period | during blanking period (3 months) | Atrial arrhythmia recurrence during blanking period (3 months) after one or two procedures with/without antiarrhythmic medications |
| Atrial tachycardia or flutter recurrence | 1 year | Atrial tachycardia or flutter recurrence during long-term follow-up after one or two procedures with/without antiarrhythmic medications |
| Atrial fibrillation recurrence | 1 year | Atrial fibrillation recurrence during long-term follow-up after one or two procedures with/without antiarrhythmic medications |
| Incidence of peri-procedural complications | Periprocedural | including stroke, cardiac tamponade, esophageal injury, phrenic nerve damage, and death |
| Rate of first-pass isolation or first-freeze isolation | during procedure | — |
| LA pressure, mmHg (max/min/mean) | during procedure | — |
| Ablation time (minutes) | during procedure | — |
| Fluoroscopy time (minutes) | during procedure | — |
| LA dwelling time | during procedure | — |
| Ablation time (seconds) | during procedure | — |
| Quality of life changes at 12 months compared to baseline | 1 year | Scores from the SF-36 questionnaire will be compared between baseline and the 1-year follow-up period. Scores will be scaled from 0 to 100, with higher values indicating better quality of life |
| Number of repeat procedures | 1 year | — |
| Procedure duration (minutes) | during procedure | — |
Countries
South Korea
Outcome results
None listed