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

NCT06748157 | Active Not Recruiting DMC FDA Device

• 1 other identifier: STUDY-24-00641
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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. 1.early (0-2 months) post-ablation arrhythmias that occur in the immediate post-ablation time period
2. 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).

Conditions

Atrial Fibrillation

Keywords

AFib; Neuromodulation; Prevent AFib

Outcome Measures

Primary Outcomes (1)

• AF/AFL occurrence

  Burden of AF/AFL (defines as 30 seconds or longer) during the 2-months and 6-months period after ablation measured using ECG-patch monitoring and daily RR2 single lead ECG.

  at 2-months and 6-months post-ablation procedure

Secondary Outcomes (12)

• Time to first Atrial tachycardia (AT) or Atrial Fibrillation (AF) recurrence

  2-month and 6-month post-ablation procedure

• Number of arrythmia occurrences

  2-month and 6-month post-ablation procedure

• Number of Atrial Arrythmia Symptoms

  6-month post-ablation procedure

• Time to first Atrial tachycardia (AT) or Atrial Fibrillation (AF) recurrence

  6 months post-ablation

• Quality of Life measured using The European Heart Rhythm Association (EHRA) score

  Baseline, 2-months, and 6-months

Study Arms (2)

Participants with CardiaCare RR2

ACTIVE COMPARATOR

Participants undergoing Neuromodulation Sessions (mNVS) and Active Median/Vagal Stimulation. Patients will receive training on the RR2 for home-care use, by study personnel either in person or via a video conference meeting. An instructional video will also be available for users.

Device: CardiaCare RR2

Participants with Sham Device

SHAM COMPARATOR

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

Device: Sham Device

Interventions

CardiaCare RR2 DEVICE

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.

Participants with CardiaCare RR2

Sham Device DEVICE

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

Participants with Sham Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women ages ≥18 years
• Patients planned to undergo or undergoing AF ablation for paroxysmal or persistent AF and able to be randomized within 48 hours of the ablation procedure.
• Ability and willingness to sign an informed consent form.
• Ability and willingness to use CardiaCare RR2 device, continuous ECG monitoring, and has an available SmartPhone.

You may not qualify if:

• Rheumatic heart disease
• Extensive atrial disease (\* some patients may be determined to be screen failures following the ablation procedure).
• Moderate to severe mitral stenosis or history of mitral valve replacement
• Pacemaker or CRTD or any implanted electrical stimulating device
• Unilateral or bilateral vagotomy
• Peripheral neuropathy affecting the tested upper extremity.
• Severe heart failure (New York Heart Association Class III or IV) within 90 days.
• Recent (within 90 days) stroke or transient ischemic attack.
• Recent (within 90 days) myocardial infarction.
• Pregnancy or breast feeding.
• Life expectancy \<1 year for any medical condition
• Currently enrolled in another study that would interfere with this study
• Unsuitable for participating in the study according to attending physician

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Ziv HealthCare Ltd.: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Vivek Reddy, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Mohit Turagam, MD

  Icahn School of Medicine at MS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Patient and investigator are blinded, as is the statistician
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director EP Service

Model Details: 1:1 randomization

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: December 27, 2024
• Study Start: October 2, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)