臨床研究等提出・公開システム

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

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

Sakamoto Kazuo

Coronary Care Unit, Kyushu University Hospital

3-1-1 Maidashi Higashi-ku Fukuoka, Japan

sakamoto.kazuo.283@m.kyushu-u.ac.jp

Nagayama Tomomi

Center for Clinical and Translational Research, Kyushu University Hospital

3-1-1 Maidashi Higashi-ku Fukuoka, Japan

+81-92-642-6290

nagayama.tomomi.325@m.kyushu-u.ac.jp

Recruiting

June. 01, 2026

Interventional

single arm study

open(masking not used)

no treatment control/standard of care control

single assignment

treatment purpose

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.

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.

Both

Atrial fibrillation

Additional ablation procedures

Atrial fibrillation

Ablation

D001281

D017115

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

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

+81-92-641-1151

Mar. 24, 2026

No

none