Radiofrequency ablation
ProcedureRadiofrequency ablation of pulmonary veins
NCT Number: NCT07034378
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
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Seoul National University Bundang Hospital, Seongnam-si, South Korea
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Radiofrequency ablation of pulmonary veins
Cryoablation of pulmonary veins + posterior wall isolation
Standard cryoablation of pulmonary veins
Time frame: 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
Time frame: during blanking period (3 months)
Atrial arrhythmia recurrence during blanking period (3 months) after one or two procedures with/without antiarrhythmic medications
Time frame: 1 year
Atrial tachycardia or flutter recurrence during long-term follow-up after one or two procedures with/without antiarrhythmic medications
Time frame: 1 year
Atrial fibrillation recurrence during long-term follow-up after one or two procedures with/without antiarrhythmic medications
Time frame: Periprocedural
including stroke, cardiac tamponade, esophageal injury, phrenic nerve damage, and death
Time frame: during procedure
Time frame: during procedure
Time frame: during procedure
Time frame: during procedure
Time frame: during procedure
Time frame: during procedure
Time frame: 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
Time frame: 1 year
Time frame: 1 year
AF burden assessed at 12 months after ablation
Time frame: during procedure
Asan Medical Center
Other
Comparison of Extended Cryoballoon Ablation, Standard Cryoballoon Ablation, and Radiofrequency Catheter Ablation in Patients With Persistent Atrial Fibrillation: A Multicenter, Randomized Controlled Clinical Trial
Acronym: EXCAPE-AF
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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