Related Experiment Video
Updated: Jun 30, 2026
Robotic Ablation of Atrial Fibrillation
Published on: May 29, 2015
PERSIST-PWI trial: Rationale and design of a multicenter randomized controlled trial comparing pulmonary vein
Yasuo Okumura1, Michifumi Tokuda2, Koichi Nagashima1
1Division of Cardiology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan.
Background:
Pulmonary vein isolation (PVI) is the cornerstone of atrial fibrillation (AF) ablation, yet outcomes remain suboptimal in persistent AF. With thermal energy, adjunctive left atrial posterior wall isolation (PWI) has shown inconsistent benefit, partly owing to limited lesion durability and esophageal safety constraints. Pulsed field ablation (PFA) may enable safer, more reproducible posterior wall lesion sets.
Objective:
This study aimed to compare PVI alone with PVI plus PWI using the FARAPULSE PFA system in symptomatic, drug-refractory persistent AF.
Methods:
PERSIST-PWI is an investigator-initiated, multicenter, open-label, parallel-group randomized controlled trial at approximately 60 sites in Japan. 500 patients with persistent AF (AF duration ≤3 years) will be randomized 1:1 to PVI alone or PVI + PWI. Pre- and postablation 3-dimensional mapping with OPAL HDx (FARAVIEW) is mandated. Follow-up includes visits at 3, 6, and 12 months with 12-lead electrocardiograms (ECGs), 24-hour Holter monitoring at 6 and 12 months, and biweekly plus symptom-triggered portable ECG transmissions.
Results:
The primary effectiveness endpoint is acute ablation success and freedom from clinically meaningful treatment failure from the end of an 8-week blanking period through 12 months, defined as documented AF/atrial flutter/atrial tachycardia (≥30 seconds on ambulatory monitoring or ≥10 seconds on 12-lead ECG), repeat ablation, electrical cardioversion, or initiation/escalation of class I/III antiarrhythmic drugs including amiodarone. Key secondary endpoints include AF burden, quality of life (Atrial Fibrillation Effect on Quality-of-Life questionnaire), and predefined safety events.
Conclusion:
PERSIST-PWI will provide randomized evidence on whether PFA-enabled PWI adds clinical benefit beyond PVI while maintaining safety in persistent AF, thereby informing contemporary ablation strategies.
