Arrhythmias & electrophysiologyRandomised controlled trial
Transcutaneous Electrical Vagus Nerve Stimulation to Suppress Ventricular Premature Complexes (TREAT-PVC)
- sham-controlled, double-blind, randomized trial
Authors' conclusion
LLTS and sham stimulation produced parallel results, indicating the presence of significant placebo effects. Future transcutaneous neuromodulation studies should include placebo effects into sample size calculation. (LLTS to Treat Premature Ventricular Contractions [TREAT-PVC]; NCT04909528).
Study context
- Population
- Patients with idiopathic PVC and >10% PVC burdenrandomized, 96 included into final analysis
- Participants
- 100 patients
- Comparison
- Low-level tragus stimulation (LLTS) vs sham stimulation to the earlobe
- LLTSn = 48
- shamn = 48
- Primary endpoint
- Reduction of PVC burden assessed by 10-day ambulatory electrocardiographic monitoring
- Follow-up
- 6 months
Primary result
As reported in the abstract
| Group | Value | P (within group) |
|---|---|---|
| LLTS | median value 18.7% to 11.1% | P < 0.01 |
| sham | median value 16.7% to 12.6% | P < 0.01 |
Further findings
Baseline PVC burden · Baseline characteristics were balanced between groups
Adherence to the study protocol
Skin sympathetic nerve activity and inflammatory markers (tumor necrosis factor-α, interleukin-1, and interleukin-6)
- Remained unchanged in both groups
Heart rate variability parameters
- No differences between the 2 groups
- P > 0.05 for all parameters
- Similar significant changes in each group (higher low-frequency, high-frequency, and very-low-frequency power; and a lower low-frequency/high-frequency ratio)
Original publication
Transcutaneous Electrical Vagus Nerve Stimulation to Suppress Ventricular Premature Complexes (TREAT-PVC). JACC Clin Electrophysiol. Published 26 April 2026. doi:10.1016/j.jacep.2026.01.011
Summarised from the published abstract; every number is checked against it