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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2072260027

Enrollment

Registered

2026-05-12

Start date

2026-06-02

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial fibrillation Atrial fibrillation

Interventions

Additional ablation procedures

D017115

Ablation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
Rate of recurrence of atrial fibrillation and atrial tachycardia within 3 months after catheter ablation	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Contacts

Public ContactTomomi Nagayama

Center for Clinical and Translational Research, Kyushu University Hospital

nagayama.tomomi.325@m.kyushu-u.ac.jp+81-92-642-6290

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026