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

NCT06748157 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2025-05-06

No results posted yet for this study

Summary

Determine the role of vagal/median nerve stimulation using the CardiaCare RR2 home care wearable neuromodulation system on suppressing atrial arrhythmias and related symptoms in patients who have undergone AF ablation. The study population will be comprised of adults (age ≥18 yrs.) who have undergone AF ablation for paroxysmal or persistent AF.

The study will assess the ability of neuromodulation, using the CardiaCare RR2 home care wearable, to suppress the following:

1. early (0-2 months) post-ablation arrhythmias that occur in the immediate post-ablation time period
2. AF/AT/AFL recurrences between months 2-6 post-ablation.This is a prospective, controlled, double-blind, randomized trial. The first 15 patients will not be randomized and will receive the active median/vagal stimulation only (open label).

The Study will be conducted in up to 1 clinical site in the United States. This study will have 1:1 randomization (active median/vagal stimulation vs sham). The study has been given NSR designation from FDA--NO IDE.

Conditions

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

Sponsors & Collaborators

Principal Investigators

  • Vivek Reddy, MD · Icahn School of Medicine at Mount Sinai

  • Mohit Turagam, MD · Icahn School of Medicine at MS

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-02
Primary Completion
2026-04-30
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06748157 on ClinicalTrials.gov