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ENROLLING BY INVITATION
NCT07362134
NA

Pulsed-Field Ablation for Recurrent Atypical Atrial Flutter

Sponsor: Taipei Veterans General Hospital, Taiwan

View on ClinicalTrials.gov

Summary

Recurrent atypical atrial flutter (AFL) after prior atrial fibrillation or flutter ablation remains challenging to treat, and conventional radiofrequency ablation may be limited by incomplete lesion formation and risk of collateral damage. Pulsed-field ablation (PFA) uses non-thermal electric fields to create myocardial lesions with relative sparing of surrounding tissues and may improve the safety and efficacy of ablation for atypical AFL. This prospective, non-randomized, single-arm study will enroll approximately 30 patients with clinically documented recurrent atypical AFL who are referred for elective catheter ablation using a point-by-point pulsed-field ablation system. During the index procedure, detailed electroanatomic mapping will be performed to identify the critical isthmus or circuit, followed by linear or focal PFA and confirmation of bidirectional conduction block. The primary safety endpoint is the incidence of procedure- and device-related primary adverse events. The primary effectiveness endpoint is acute procedural success, defined as termination of atypical AFL and establishment of bidirectional block across the targeted lesion set at the end of the procedure. Secondary endpoints include recurrence of any atrial arrhythmia during 12-month follow-up, durability of the linear lesions assessed by repeat electroanatomic mapping at 3 months, changes in atrial scar on cardiac MRI, peri-procedural changes in blood biomarkers, and the rate of serious adverse events related to the procedure or study device.

Official title: The Application of Point-by-point Pulsed-Field Ablation for Recurrent Atypical Flutter: Safety, Acute Success, Efficacy, and Outcome

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-01-09

Completion Date

2028-12-31

Last Updated

2026-02-17

Healthy Volunteers

No

Interventions

PROCEDURE

Point-by-point pulsed-field catheter ablation

Point-by-point pulsed-field catheter ablation delivered with a dual-energy pulsed field/radiofrequency ablation system. The procedure is guided by 3D electroanatomic mapping to identify the critical isthmus or scar-related circuit responsible for recurrent atypical atrial flutter. Linear or focal lesions are created with point-by-point pulsed-field applications along the targeted line to achieve arrhythmia termination and durable bidirectional conduction block. Radiofrequency energy using the same catheter and generator may be applied only as a bail-out strategy if pulsed-field ablation alone fails to achieve the acute endpoint.

Locations (1)

Taipei Veterans General Hospital

Taipei, Taiwan