Non-Invasive Median Nerve Stimulation to Attenuate Atrial Tachyarrhythmias After Catheter Ablation for Atrial Fibrillation

NAActive, not recruitingINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

October 2, 2024

Primary Completion Date

April 30, 2026

Study Completion Date

December 31, 2026

Conditions
Atrial Fibrillation
Interventions
DEVICE

CardiaCare RR2

CardiaCare has developed a wrist band that delivers non-invasive neuromodulation to the median nerve to elicit a vagal response (Median-Vagus nerve stimulation-mVNS). The device is in the post-prototype development stage and is ready for human clinical trials. The CardiaCare RR2 device has already been approved by the IRB of the Chaim Sheba Medical Center, IL and the IL MOH (Ministry of Health) in an already completed pilot clinical trial for modulating AF.

DEVICE

Sham Device

Sham device will be dispensed, which will create a sensation but not provide therapy

Trial Locations (1)

10029

Icahn School of Medicine at Mount Sinai, New York

All Listed Sponsors
collaborator

Ziv HealthCare Ltd.

INDUSTRY

lead

Icahn School of Medicine at Mount Sinai

OTHER

NCT06748157 - Non-Invasive Median Nerve Stimulation to Attenuate Atrial Tachyarrhythmias After Catheter Ablation for Atrial Fibrillation | Biotech Hunter | Biotech Hunter