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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extended cryoballoon ablation | Experimental | The method of ablation, size of balloon, freezing time, and booster freezing will be decided by the participating center's policy or physician's discretion. Ablation strategies described above are highly recommended for all participants. Additional posterior wall isolation should be performed by single 120 to 180 second CB application delivered at each site. Maximal posterior wall debulking should be attempted, although complete isolation may not always be achievable, as we considered that a large scar created by the CB application would provide sufficient anti-arrhythmic effects in terms of suppressing AF. The number and duration of CB application should be recorded in the case report form. Successful posterior wall isolation should be determined by 3-dimensional electro-anatomical mapping or differential pacing. The method and achievement of posterior wall isolation should be recorded in the case report form. |
|
| Standard cryoballoon ablation | Active Comparator | Application of TTI + 2 minutes or 180 seconds single-freezing is recommended when time-to-isolation (TTI) <60 seconds. Additional 120 seconds of booster-freezing after TTI + 2 or 180 seconds initial freezing is recommended when TTI value >60 seconds, or PV potentials were not discernable in the Achieve multipolar catheter. If temperatures below -40°C cannot be achieved due to improper occlusion or TTI > 90 seconds, freezing should be discontinued and reposition of balloon is recommended. Segmental ablation is allowed when the proper occlusion of PV by balloon cannot be achieved. Continuous phrenic capture should be monitored during the procedure in the right PVs to avoid phrenic nerve injury. Stop ablation immediately if phrenic nerve damage is suspected. No further ablation would be performed if the phrenic nerve damage is suspected. Touch-up ablation using irrigated radiofrequency ablation catheter would be permitted with conventional mapping method. |
|
| Radiofrequency ablation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency ablation | Procedure | Radiofrequency ablation of pulmonary veins |
| |
| Measure | Description | Time Frame |
|---|---|---|
| the incidence rates of atrial tachyarrhythmias | 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 | 3-month blanking period post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Atrial arrhythmia recurrence during blanking period | Atrial arrhythmia recurrence during blanking period (3 months) after one or two procedures with/without antiarrhythmic medications | during blanking period (3 months) |
| Atrial tachycardia or flutter recurrence |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | South Korea | ||||
| Asan Medical Center |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| ID | Term |
|---|---|
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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| Active Comparator |
CARTO system (Biosense-Webster, USA): Ablation index (AI) CLOSE protocol . Navistar Smart-touch surround-flow catheter; 25-40 watts of energy; 40 seconds time limit; 10-30 gram of contact force; 40 seconds time limit; targeting AI value of 550 in anterior wall and 400 in the posterior wall; interlesion distance ≤6mm; using automatic lesion annotation (Visitag™) - type 3 tagging, 3mm stability for 5 seconds, force >5g over 50% of time; target AI value could be reduced (450 in anterior wall and 350 in posterior wall) according to the participating center's policy. Ensite NavX system (Abbott, USA) : TactiCath™ Quartz ablation catheter; delivering 25-35 watts of energy; 40 seconds time limit; 10-30 gram of contact force; using automatic lesion annotation (Automark Module), target lesion index value of 5-5.5 in the posterior wall and 5.5-6 in the anterior wall. |
|
| Extended cryoballoon ablation |
| Procedure |
Cryoablation of pulmonary veins + posterior wall isolation |
|
| Standard cryoballoon ablation | Procedure | Standard cryoablation of pulmonary veins |
|
Atrial tachycardia or flutter recurrence during long-term follow-up after one or two procedures with/without antiarrhythmic medications |
| 1 year |
| Atrial fibrillation recurrence | Atrial fibrillation recurrence during long-term follow-up after one or two procedures with/without antiarrhythmic medications | 1 year |
| Incidence of peri-procedural complications | including stroke, cardiac tamponade, esophageal injury, phrenic nerve damage, and death | Periprocedural |
| Rate of first-pass isolation or first-freeze isolation | during procedure |
| Procedure duration (minutes) | 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 | 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 | 1 year |
| Number of repeat procedures | 1 year |
| AF burden by 2-week patch monitoring | AF burden assessed at 12 months after ablation | 1 year |
| LA pressure, mmHg (max/min/mean) | during procedure |
| Seoul |
| 05505 |
| South Korea |
| Asan Medical Center | Seoul | South Korea |
| D013568 |
| Pathological Conditions, Signs and Symptoms |