Advancing neuromodulation through clinical research
StimCardio Medical is conducting a structured, multi-stage clinical program based on discussions and feedback from the FDA to evaluate its non-invasive, wearable neuromodulation platform.
Clinical studies are designed to assess system feasibility and safety, usability, physiological effects, clinical efficacy, and rhythm-related markers, with atrial fibrillation as the lead indication.
Pilot randomized controlled study
This randomized, sham-controlled pilot study was designed to evaluate system behavior and rhythm-related markers under controlled conditions. Study findings were presented at a major international electrophysiology meeting (HRS 2025 - San Diego, CA).
First clinical evidence of atrial arrhythmia management using non-invasive median nerve neuromodulation
This study provides the first clinical evidence demonstrating atrial arrhythmia management using non-invasive median nerve neuromodulation. Using direct epicardial mapping during open-heart surgery, investigators observed acute improvements in atrial electrophysiology, including enhanced conduction and favorable changes in atrial activation patterns, voltage and slope, all indicating an anti-arrhythmic effect.
First-in-Human (FIH) feasibility study
This study evaluated early system feasibility and performance in a real-world, at-home setting following cardioversion. Study findings were presented at a major international electrophysiology meeting.
Presentations
We are committed to scientific transparency and sharing our research with the medical community. The following data have been presented at international medical conferences.
FAQs About the Clinical Research
Is the StimCardio system approved for clinical use?
No. The StimCardio platform and Rhyvive wearable are investigational and are not approved or cleared by regulatory authorities for diagnosis or treatment.
Is the device available to patients today?
No. The device is investigational and is only available to participants enrolled in approved clinical studies.
What patient populations are being studied?
Current clinical studies focus on patients with atrial fibrillation, including paroxysmal and post-ablation populations. Additional indications may be explored as the platform evolves.
Is this intended to replace medications or ablation?
No. Rhyvive is under investigation for use as a physician-prescribed adjuvant to the standard of care and is not approved as a replacement for medications, ablation, or other interventions.
Can this device treat atrial fibrillation?
Rhyvive is currently being studied in clinical research. It is not approved to treat atrial fibrillation or any other condition.
Is this an emergency device?
No. Rhyvive is not designed to detect or respond to medical emergencies. Individuals experiencing symptoms or an emergency should seek immediate medical care.
How can providers learn more or participate in research?
Healthcare professionals interested in learning more or participating in clinical research may contact StimCardio Medical directly.