NCT07362134

Pulsed-Field Ablation for Recurrent Atypical Atrial Flutter

ENROLLING BY INVITATION NA Last updated 17 February 2026

What this trial tests

NA trial testing Point-by-point pulsed-field catheter ablation in Atypical Atrial Flutter in 30 participants. Enrolling by invitation.

Timeline

9 January 2026

Primary endpoint
31 December 2028

31 December 2028

Quick facts

Lead sponsor	Taipei Veterans General Hospital, Taiwan
Phase	NA
Status	ENROLLING BY INVITATION
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	9 January 2026
Primary completion	31 December 2028
Estimated completion	31 December 2028
Sites	1 location across Taiwan

Drugs / interventions tested

• Point-by-point pulsed-field catheter ablation

Conditions studied

• Atypical Atrial Flutter — all drugs for Atypical Atrial Flutter →
• Atrial Flutter — all drugs for Atrial Flutter →

Sponsor

Taipei Veterans General Hospital, Taiwan

Who can join

Adults 18 to 80, any sex, with Atypical Atrial Flutter or Atrial Flutter. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.