Atlanta and Los Angeles – September 20, 2026 -- StimCardio Medical reported that patients treated with non-invasive median nerve stimulation (MNS) after atrial fibrillation (AF) ablation showed 90.0% freedom from atrial arrhythmias at six months, compared with 80.8% for those receiving sham treatment, though the difference did not reach statistical significance. The randomized, double-blind, sham-controlled NeuroPulse pilot study was presented as late-breaking clinical science at HRX Live 2026 and simultaneously published in the peer-reviewed journal Heart Rhythm.
Post-blanking analysis finds statistically significant drop in arrhythmia events
In a sensitivity analysis conducted after the 60-day blanking period, patients receiving MNS recorded 12 recurrent atrial arrhythmia events versus 28 in the sham group, a statistically significant reduction (p=0.025). No MNS- or device-related serious adverse events were reported across the trial.
Three-center trial enrolled 77 patients with paroxysmal or persistent AF
The prospective study randomized 77 adults 1:1 to active MNS or sham therapy, initiated within 48 hours of catheter ablation and continued for six months. The modified intention-to-treat analysis, assessed following the 60-day blanking period, included 59 patients. Lead investigator Vivek Y. Reddy, MD, Director of Cardiac Arrhythmia Services at The Mount Sinai Hospital, presented the results.
Findings target a persistent efficacy gap despite ablation advances
Reddy noted that in the 2023 ADVENT trial he led, one-year treatment success rates were 73.3% with pulsed field ablation and 71.3% with conventional thermal ablation, underscoring a long-standing efficacy plateau in AF treatment. "The NeuroPulse results provide an encouraging clinical signal that non-invasive, wearable neuromodulation following ablation may offer a fundamentally different way to approach that remaining challenge," Reddy said, adding that the findings warrant confirmation in a larger multi-center trial.
StimCardio positions wrist-worn device as adjunct therapy beyond ablation
StimCardio Medical is developing Rhyvive, an investigational, physician-prescribed, wrist-worn device designed as a closed-loop system that delivers personalized neuromodulation informed by continuous physiological sensing under physician oversight. The company, headquartered in Los Angeles, said it plans to advance the technology into a pivotal trial following the pilot results. Rhyvive remains limited under U.S. law to investigational use.