An interventional study of cryoballoon ablation and implantable loop recorder insertion in Atrial Fibrillation, Persistent, sponsored by Seoul National University Hospital. Active, not recruiting at 1 site in South Korea. Open to participants aged 20 Years to 79 Years. Per ClinicalTrials.gov, last updated 2026-08-20.
Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Other
This study aimed to evaluate the efficacy of Cryoablation in patients with early persistent atrial fibrillation as a first index procedure using continuous cardiac rhythm monitoring.
Atrial fibrillation is the most common cardiac arrhythmia. With the population aging, the prevalence of atrial fibrillation is increasing globally. Recently, Cryoablation has been demonstrated non-inferior efficacy and safety compared with catheter ablation in atrial fibrillation patients. Cryoablation with the simplicity of the procedure brought the substantial shortening of the total procedure time compared to catheter ablation with comparable long-term atrial fibrillation free survival and procedure-related adverse events. However, most of the previous studies that reported non-inferior efficacy and safety of Cryoablation versus catheter ablation were only included patients with paroxysmal atrial fibrillation. The long-term efficacy of Cryoablation in patients with persistent atrial fibrillation is controversial.
In patients with persistent atrial fibrillation, pulmonary vein isolation alone showed comparable atrial fibrillation recurrence rate compared to pulmonary vein isolation with additional ablation, including linear ablation or ablation of complex fractionated electrograms.
In a recent study, Cryoablation was safe and had good outcomes in patients with persistent and long-standing persistent atrial fibrillation within relatively short procedure time; atrial fibrillation recurrence rate was 36% in persistent atrial fibrillation and 43% in long-standing persistent atrial fibrillation. Among patients with persistent atrial fibrillation ≤1 year, pulmonary vein isolation using cryoballoon had 39% of any atrial fibrillation/atrial tachycardia recurrence rate during a 1-year follow-up. Pre-predictor such as smaller left atrium size or atrial fibrillation history less than three years was associated with a better outcome of atrial fibrillation cryoablation. Therefore, early ablation of persistent atrial fibrillation using Cryoablation may be related to a good outcome that is nearly comparable to those with paroxysmal atrial fibrillation. Namely, pulmonary vein isolation by Cryoablation could be reasonable as the first procedure in patients with early persistent atrial fibrillation. Based on the results of the STOP Persistent atrial fibrillation trial, the Arctic Front Advance cryoablation system (Medtronic) was granted an expanded indication by the US Food and Drug Administration for the treatment of recurrent, drug-refractory, symptomatic, persistent atrial fibrillation. It is the first ablation catheter in the United States to receive an indication for persistent-as opposed to paroxysmal-atrial fibrillation.
Not only atrial fibrillation recurrence merely defined as any atrial fibrillation episode lasting 30 seconds or more, but the atrial fibrillation burden is also a relevant indicator for evaluation of procedure success. Among patients with paroxysmal atrial fibrillation, a recent prospective study reported that atrial fibrillation burden dramatically decreased after Cryoablation by 99% . There was limited data about the efficacy of Cryoablation in patients with early persistent atrial fibrillation evaluated by actual atrial fibrillation burden using continuous cardiac rhythm monitoring.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 130 is close to the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Either two conditions
Exclusion Criteria:
Following enrollment, an implantable loop recorder is implanted in all participants for the purpose of arrhythmia (any atrial fibrillation or atrial tachycardia) detection (Reveal LINQ, Medtronic, Minneapolis, MN).
Procedure: cryoballoon ablation · Device: implantable loop recorder insertion
Cryoballoon ablation for the treatment of atrial fibrillation
The device called a implantable loop recorder, is placed just under the skin of one's chest during a minor surgery.
Change of implantable cardiac monitor-detected atrial fibrillation/atrial flutter burden.
The percentage of time spent in atrial fibrillation (hours of atrial fibrillation/hours of monitoring) during the first year after pulmonary vein isolation (excluding a 3-month window) compared to pre-ablation atrial fibrillation/atrial flutter burden.
Time frame: After cryoablation (between 3-month and 1-year) and pre-ablation
Time to the first recurrence of atrial fibrillation/atrial flutter
Atrial fibrillation/atrial flutter recurrence, defined as an episode of atrial arrhythmia beyond the first 3 months post-ablation (blanking period), lasting for 30 seconds or more
Time frame: From 3-month after cryoablation to the removal of the implantable loop recorder, up to 3years.
Recurrence nature of atrial fibrillation
paroxysmal atrial fibrillation or persistent atrial fibrillation
Time frame: From 3-month after cryoablation to the removal of the implantable loop recorder, up to 3years.
36-Item Short Form Health Survey composite scores
Quality of life assessed with the use of the Medical Outcomes Study 36-Item Short-From Health Survey \[SF-36\]; range 0 to 100, with higher scores indicating better quality of life
Time frame: Pre-ablation and 1-year after ablation
European Heart Rhythm Association score
The European Heart Rhythm Association score of atrial fibrillation (or EHRA score) is a classification system for the extent of atrial fibrillation. It places patients in one of four categories based on how much they are limited during physical activity; the limitations/symptoms are in regard to normal breathing and varying degrees in shortness of breath and/or angina. EHRA Class / Symptoms I- No symptoms. II- Mild symptoms; normal daily activity not affected. III- Severe symptoms; normal daily activity affected. IV- Disabling symptoms; normal daily activity discontinued.
Time frame: Pre-ablation and 1-year after ablation
Atrial fibrillation/atrial flutter recurrence and changes in atrial fibrillation/atrial flutter burden
Atrial fibrillation/atrial flutter recurrence and changes in AF/AT burden from 3-month after cryoablation to the removal of the implantable loop recorder
Time frame: From 3-month after cryoablation to the removal of the implantable loop recorder, up to 3years.
Plan to share: No
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Seoul National University Hospital