The randomized, double-blind study evaluated 77 patients, with a modified intention-to-treat analysis of 59 individuals following a 60-day blanking period. While the primary finding of 90.0% arrhythmia freedom compared to 80.8% in the sham group did not reach statistical significance, secondary sensitivity analysis showed a clear reduction in events: 12 occurrences in the stimulation group versus 28 in the sham group (p=0.025). No serious adverse events related to the device were reported.
StimCardio Reports Success in NeuroPulse Trial for AF Ablation Recovery
Patients recovering from atrial fibrillation ablation showed a 90% freedom from recurrent arrhythmias after six months of using StimCardio’s non-invasive median nerve stimulation. The pilot study, presented at HRX Live 2026, suggests that wearable neuromodulation may bridge the long-standing efficacy gap left by conventional ablation procedures.
Dr. Vivek Y. Reddy, Director of Cardiac Arrhythmia Services at The Mount Sinai Hospital, led the research, which shifts the therapeutic focus away from direct cardiac tissue destruction. Instead, the approach targets peripheral neural pathways to influence autonomic regulation of heart rhythm. StimCardio is currently developing Rhyvive, a physician-prescribed wrist-worn device designed to deliver this neuromodulation in a home setting, providing electrophysiologists with an adjunct tool to extend care beyond the clinical procedure.
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