Evaluation of the Efficacy of Rotor-Guided Pulsed Field Ablation for Extended Pulmonary Vein Isolation in Patients with Persistent Atrial Fibrillation

Evaluation of the Efficacy of Rotor-Guided Pulsed Field Ablation for Extended Pulmonary Vein Isolation in Patients with Persistent Atrial Fibrillation - Rotor guided PFA EPVI trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000059827

Enrollment

150

Registered

2025-12-01

Start date

2025-12-01

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

Interventions

ExTRa Mapping of the left atrium and pulmonary vein (PV) antrum will be performed prior to pulmonary vein isolation (PVI). Areas with a non-passive ratio &gt

=25% by Advisor HD-Grid will be marked on the NAVX system. In addition to standard PVI, pulsed field ablation (PFA) will be applied to modify the rotor areas around the left atrial PV antrum. No addit

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: First time ablation procedure for persistent atrial fibrillation Patients from who we get written informed consent

Exclusion criteria

Exclusion criteria: Age >= 85 years Estimated glomerular filtration rate (eGFR) < 30 mL/min Left atrial diameter >= 50 mm on transthoracic echocardiography Left ventricular ejection fraction (LVEF) <= 35% chronic heart failure of NYHA class IV Patients with implanted pacemakers or implantable cardioverter-defibrillators (ICDs)

Design outcomes

Primary

Measure	Time frame
Atrial arrhythmia recurrence beyond 90 days after catheter ablation for atrial fibrillation	—

Secondary

Measure	Time frame
Safety Procedure time Association between data obtained from ExTRa Mapping and recurrence rate AF/AT burden at 3 and 12months (Holter ECG or Long-term Holter ECG) Recurrence of atrial arrhythmias after additional ablation performed following recurrence after 90 days post-procedure	—

Countries

Japan

Contacts

Public ContactYuya Suzuki

Kita-Harima Medical Center Cardiology

yuyasuzuki1217@gmail.com0794-88-8800

Outcome results

None listed

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