Arrhythmias & electrophysiologyRandomised controlled trial
TWOSOME trial: Randomized comparison of single-shot vs single-tip pulsed field ablation for pulmonary vein isolation
- Randomized comparison
- head-to-head
Authors' conclusion
Both PFA systems achieved high acute PVI rates with favorable 1-year clinical outcomes. Single-shot PFA was associated with shorter procedure times and longer fluoroscopy times, whereas single-tip PFA allowed adjunctive ablation when required and was associated with higher postprocedural troponin T levels.
Study context
- Population
- Patients with paroxysmal atrial fibrillation undergoing index pulmonary vein isolationassigned to the single-shot or the single-tip pulsed field ablation (PFA) group
- Participants
- 100 patients
- Comparison
- single-shot PFA vs single-tip PFA
- Primary endpoint
- Arrhythmia-free survival
- Follow-up
- 12 months
Primary result
As reported in the abstract
P = 0.46
Secondary outcomes
Total procedure time · reduced with single-shot PFA
P < 0.001
Fluoroscopy time · longer with single-shot PFA
P < 0.001
Acute pulmonary vein isolation (PVI)
- Acute PVI achieved
- 100%
New-onset arrhythmias
- New-onset arrhythmias could only be treated in the single-tip PFA group
- 6%
Troponin levels
- Troponin levels were higher with single-tip PFA
Safety
| Outcome | single-shot PFA | single-tip PFA |
|---|---|---|
| Major complications | ||
| non-PFA-related stroke | 1 | Not reported in the abstract |
| pericardial tamponade | Not reported in the abstract | 1 |
Major complications
- No permanent sequelae occurred
Original publication
TWOSOME trial: Randomized comparison of single-shot vs single-tip pulsed field ablation for pulmonary vein isolation. Heart Rhythm. Published 5 May 2026. doi:10.1016/j.hrthm.2026.04.049
Summarised from the published abstract; every number is checked against it