A single-center, prospective, randomized trial to evaluate the efficacy of ablation using the spatiotemporally distributed potentials visualized by a fractionation map compared with ablation using low-potential regions visualized by a voltage map in patients with recurrent sustained atrial fibrillation (ARCHERY trial).

JRCT ID: jRCTs042230101

Registered date:02/11/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Recurrent Persistent Atrial Fibrillation
• Date of first enrollment: 02/11/2023
• Target sample size: 30
• Study type: Interventional
• Intervention(s): 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.

Outcome(s)

• Primary Outcome: AF burden: Percentage of AF duration 52 weeks after catheter ablation

Secondary Outcome

AF recurrence: presence or absence of AF lasting longer than 6 minutes 52 weeks after catheter ablation
Recurrent AT: AT lasting >6 minutes 52 weeks after catheter ablation
Recurrent AF/AT: AF/AT lasting longer than 6 minutes 52 weeks after catheter ablation
Recurrence of persistent AF: presence of AF lasting more than 7 days (or more than 1 day) 52 weeks after catheter ablation
Recurrence of persistent AT: presence of AT lasting more than 7 days (or more than 1 day) 52 weeks after catheter ablation
Recurrence of persistent AF/AT: AF/AT lasting more than 7 days (or more than 1 day) in the 52 weeks after catheter ablation
AT burden: Percentage of AT duration (duration per day) in 52 weeks after catheter ablation
AF/AT burden: Percentage of AF/AT duration (duration per day) for 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, change in valvular disease
Therapeutic interventions for recurrent AF/AT (antiarrhythmic drugs, cardioversion, recatheter ablation)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. patients over 18 years of age
2. Patients undergoing a second 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.

Exclude 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)

Related Information

• Primary Sponsor: Naruse Yoshihisa
• Source(s) of Monetary Support: Abbott Medical Japan LLC