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Exploratory Investigator-Initiated Clinical Trial Using an AI System to Predict Recurrence of Atrial Fibrillation and Assess Completion of Catheter Ablation

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Atrial fibrillation
Date of first enrollment	02/06/2026
Target sample size	20
Countries of recruitment
Study type	Interventional
Intervention(s)	Additional ablation procedures

Outcome(s)

Primary Outcome

Rate of recurrence of atrial fibrillation and atrial tachycardia within 3 months after catheter ablation

Secondary Outcome

1) Rate of recurrence of atrial fibrillation within 3 months after ablation 2) Rate of recurrence of atrial tachycardia within 3 months after ablation 3) Rate of recurrence of atrial fibrillation and/or atrial tachycardia during the acute phase after ablation, defined as the hospitalization period 4) Rate of recurrence of atrial fibrillation during the acute phase after ablation, defined as the hospitalization period 5) Rate of recurrence of atrial tachycardia during the acute phase after ablation, defined as the hospitalization period 6) Incidence proportion of adverse events 7) Incidence proportion of adverse events for which a causal relationship with the investigational device cannot be ruled out

Key inclusion & exclusion criteria

Age minimum	Not applicable
Age maximum	Not applicable
Gender	Both
Include criteria	1) Patients with a history of at least one prior catheter ablation procedure for atrial fibrillation and who are scheduled to undergo catheter ablation for recurrent atrial fibrillation and/or atrial tachycardia. 2) Patients for whom the CARTO 3 System is planned to be used as the three-dimensional mapping system. 3) Patients aged 18 years or older at the time of obtaining informed consent. 4) Patients who, after receiving sufficient explanation regarding participation in this clinical trial and fully understanding the study, provide written informed consent personally.
Exclude criteria	1) Patients with adult congenital heart disease (ACHD). 2) Patients who have undergone cardiac surgery involving a right atriotomy. 3) Women who are pregnant or suspected of being pregnant. 4) Patients who participated in another clinical trial or clinical study within 30 days before obtaining informed consent and received an investigational drug or were treated with an investigational device. 5) Patients who are otherwise judged by the principal investigator or sub-investigator to be inappropriate for participation in this clinical trial.