A multicenter, prospective, randomized trial to evaluate the efficacy of ablation using the spatiotemporally distributed potential visualized by a fractionation map compared to ablation using the low potential area visualized by a voltage map in patients with recurrent persistent atrial fibrillation.(ARCHERY trial)

A multicenter, prospective, randomized study to evaluate the efficacy of ablation using spatiotemporal dispersion electrograms (STDE) visualized by fractionation maps compared with ablation using low voltage zones (LVZ) visualized by voltage maps in patients with persistent atrial fibrillation recurrence after ablation without pulmonary vein reconduction (ARCHERY trial).

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs042230101

Enrollment

Registered

2023-11-02

Start date

2024-05-28

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

Recurrent Persistent Atrial Fibrillation

Interventions

In patients undergoing a second catheter ablation for persistent AF, patients will be randomized to STDE ablation or LVZ ablation and implanted with an ICM.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. patients over 18 years of age 2.Patients undergoing a second or subsequent catheter ablation for recurrent persistent AF after initial pulmonary vein isolation 3. Patients who have given their consent to participate in this study by signing a consent form in person.

Exclusion criteria

Exclusion criteria: 1. patients with AF arrest at the time of EPS 2. patients with no STDE at the time of EPS 3. patients with pulmonary veins (PV) re-conduction at the time of EPS 4. patients with allergy or serious renal disorder that precludes pre- and post-operative contrast-enhanced cardiac CT 5. patients with severely enlarged left atrium (left atrial volume >200 ml on preoperative CT analysis) 6. patients with severe left ventricular systolic dysfunction (LVEF <40%) 7. patients with symptomatic heart failure (NYHA grade III or higher) 8. other patients deemed unsuitable by the principal investigator (subinvestigator)

Design outcomes

Primary

Measure	Time frame
AF/AT burden: percentage of AF/AT duration at 52 weeks after catheter ablation	—

Secondary

Measure	Time frame
- Recurrent AF: presence or absence of AF lasting more than 6 minutes 52 weeks after catheter ablation - Recurrent AT: AT lasting >6 minutes 52 weeks after catheter ablation - Recurrent AF/AT: presence or absence of AF/AT lasting longer than 6 minutes 52 weeks after catheter ablation - Recurrence of persistent AF/AT: AF/AT lasting more than 7 days (or more than 1 day) 52 weeks after catheter ablation - AT burden: Percentage of AT duration (duration per day) in 52 weeks after catheter ablation - AF burden: Percentage of AF duration (duration per day) in 52 weeks after catheter ablation. - Comparison of CT findings: change in left atrial volume before and after surgery, presence of postoperative pulmonary vein stenosis - Comparison of echocardiographic findings: pre- and postoperative left ventricular ejection fraction, left atrial diameter, left ventricular inflow waveform, and change in valvular disease	—

Measure

Time frame

- Recurrent AF: presence or absence of AF lasting more than 6 minutes 52 weeks after catheter ablation - Recurrent AT: AT lasting >6 minutes 52 weeks after catheter ablation - Recurrent AF/AT: presence or absence of AF/AT lasting longer than 6 minutes 52 weeks after catheter ablation - Recurrence of persistent AF/AT: AF/AT lasting more than 7 days (or more than 1 day) 52 weeks after catheter ablation - AT burden: Percentage of AT duration (duration per day) in 52 weeks after catheter ablation - AF burden: Percentage of AF duration (duration per day) in 52 weeks after catheter ablation. - Comparison of CT findings: change in left atrial volume before and after surgery, presence of postoperative pulmonary vein stenosis - Comparison of echocardiographic findings: pre- and postoperative left ventricular ejection fraction, left atrial diameter, left ventricular inflow waveform, and change in valvular disease

—

Contacts

Public ContactYoshihisa Naruse

Hamamatsu University School of Medicine

ynaruse@hama-med.ac.jp+81-53-435-2356

Outcome results

None listed

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