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Pulsed-Field Ablation for Recurrent Atypical Atrial Flutter

NCT07362134 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-02-17

No results posted yet for this study

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.

Conditions

  • Atypical Atrial Flutter
  • Atrial Flutter

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.

Sponsors & Collaborators

  • Biosense Webster, Inc.

    collaborator INDUSTRY

  • Taipei Veterans General Hospital, Taiwan

    lead OTHER_GOV

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-09
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07362134 on ClinicalTrials.gov