Pulsed-Field Ablation for Recurrent Atypical Atrial Flutter
Taiwan30 participantsStarted 2026-01-09
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patients with clinically documented recurrent atypical AFL (based on ECG findings or electrophysiological study findings) after previous ablation for pulmonary vein isolation or atypical AFL within 5 years. The use of oral anticoagulation will follow current guidelines before and after the ablation procedure. In brief, oral anticoagulation will be administered for at least 4 weeks before the procedure.
✓. Patients undergoing elective AFL ablation using point-by-point PFA (BWI PFA/RFA ablation system), for any of the following types of atypical AFL: gap reentrant, perimetral, roof-dependent, bi-atrial, or scar-related atypical AFL.
✓. Patients aged ≥18 and \<80.
✓. Patient is willing and capable of providing informed consent.
✓. Patient is willing and capable of participating in all follow-up assessments and testing associated with this clinical investigation at an approved clinical investigation center.
Exclusion criteria
✕. those with AFL due to reversible conditions (e.g., thyroid disorders, acute alcohol intoxication, or recent major surgeries),
✕. those who had acute coronary syndrome, underwent percutaneous coronary intervention, or had valve or coronary bypass grafting surgery in the 90 days preceding the procedure, or receiving surgical interventions with mechanical valve implants, and
What they're measuring
1
Incidence of primary adverse events within 7 days of the index ablation procedure
Timeframe: Within 7 days after the index ablation procedure
2
Acute procedural success of atypical atrial flutter ablation
Timeframe: At the end of the index ablation procedure
✕. those with documented cardiac thrombus before the procedure, a history of cardiac thrombus, stroke, or transient ischemic attack in the previous 90 days.
✕. Categorized as vulnerable population and requires special treatment with respect to safeguards of well being.
✕. Any of the following atrial conditions:
✕. Left atrial anteroposterior diameter ≥ 5.5 cm, or if LA diameter not available, non-indexed volume \>100 ml (physician note or imaging)
✕. Current atrial myxoma
✕. Any PV abnormality, stenosis, or stenting (common and middle PVs are admissible)