Arrhythmias & electrophysiologyRandomised controlled trial
Non-Invasive Median Nerve Stimulation with a Wearable Stimulator to Reduce Atrial Arrhythmia Recurrence after Atrial Fibrillation Ablation: The NEUROPULSE Pilot
- randomized, double-blind, sham-controlled pilot study
- 3-center
Authors' conclusion
Wearable MNS after AF ablation was associated with fewer recurrent atrial arrhythmia events. This pilot study warrants confirmation in an adequately powered trial.
Study context
- Population
- Patients undergoing atrial fibrillation (AF) ablation (largely pulsed field ablation)randomized 1:1, modified intention-to-treat population 59 · median nerve stimulation (MNS) (modified intention-to-treat) 31 · sham (modified intention-to-treat) 28
- Participants
- 77 patients
- Comparison
- active MNS vs sham therapy after AF ablation
- MNSn = 31
- shamn = 28reference
Primary result
AF/atrial tachycardia/atrial flutter events · postblanking follow-up (months 2-6)
Rate ratio
17.93
95% CI 10.04–32.0
P < 0.0001
Events by treatment group
MNS
12
events
sham
243
events
MNS vs sham
rate ratio 17.93 (95% CI 10.04–32.0); P < 0.0001
As reported in the abstract
Further findings
| Outcome | MNS | sham | Estimate | P value | |
|---|---|---|---|---|---|
| AF/atrial tachycardia/atrial flutter events, excluding 1 high-burden sham outlier · postblanking follow-up (months 2-6) · more events with sham (12 vs 28) | 12 events | 28 events | rate ratio 2.17 (95% CI 1.10–4.27) | P = 0.025 | |
| AF/atrial tachycardia/atrial flutter recurrence; arrhythmia-free survival · 6 months · recurrence more frequent with sham (2 of 31 vs 5 of 28) | 6-month arrhythmia-free survival 90.0% | 6-month arrhythmia-free survival 80.8% | hazard ratio 2.15 (95% CI 0.42–11.1) | P = 0.36 | |
| 0.050.21520Ratio (log scale) |
- AF/atrial tachycardia/atrial flutter events, excluding 1 high-burden sham outlier: after excluding 1 high-burden sham outlier
Premature atrial contraction counts and patient-reported outcomes
- did not differ
Baseline characteristics
- median age
- 67 years (interquartile range 56-74 years)
- female
- 39%
- paroxysmal AF
- 68%
- redo ablation
- 27%
Blinding
- Blinding was maintained
Safety
MNS- or device-related serious adverse events
- No MNS- or device-related serious adverse events occurred
Original publication
Non-Invasive Median Nerve Stimulation with a Wearable Stimulator to Reduce Atrial Arrhythmia Recurrence after Atrial Fibrillation Ablation: The NEUROPULSE Pilot. Heart Rhythm. Published 20 September 2026. doi:10.1016/j.hrthm.2026.09.013
Summarised from the published abstract; every number is checked against it