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

NCT ID: NCT06748157

Last Updated: 2025-05-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-02
• Study Completion Date: 2026-12-31

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. 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.

Detailed Description

Study will include continuous ECG assessment at 2 (0 for the first 15 patients, open label), 6 and 22 weeks from enrollment for 2 weeks (for 4 weeks at the first measurement for the first 15 patients, open label) and at least daily single lead ECG assessments throughout the follow up period. The ECG's generated can be viewed by physicians only to assess the frequency of RR2 treatments and will not be used to alter any other aspects of standard of care, including medical management, which will continue according to standard of care throughout the study. Patients and investigators will be blinded during the trial. Patients with paroxysmal or persistent AF undergoing AF ablation will be recruited post ablation procedure during hospitalization. During screening/baseline visit, eligible patients will be randomized to either an active treatment or a sham group (1:1 accordingly). The first 15 eligible patients will not be randomized and will receive the active median/vagal stimulation only (open label).

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. Patients will be ordered to measure at home, 2 min ECG measurements with the RR2 system, two times a day throughout the study and when feeling symptoms suspected related to AF (AF/AT/PAC).

In addition, Patients will be instructed to perform Neuromodulation sessions with the RR2 home care device. Once a day for the first 2 weeks followed by three times per week for the remaining duration of the study. Additional treatments, up to once daily, will be added during this period in case the patient feels symptom, verified on single lead ECG and site staff.

Treatments will be conducted for a period of 6 months. During the study, the patients will continue to take Standard of care medication. Medications will be recorded throughout the study.

Patient Diary will be dispensed and or APP diary questioners will be used by the subject in order to document symptoms suspected as related to arrhythmia events.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Participants with CardiaCare RR2

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.

Group Type: ACTIVE_COMPARATOR

CardiaCare RR2

Intervention Type: 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 Sham Device

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

Group Type: SHAM_COMPARATOR

Sham Device

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Sham Device

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ziv HealthCare Ltd.

INDUSTRY

Sponsor Role: collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Vivek Reddy

Director EP Service

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vivek Reddy, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Mohit Turagam, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at MS

Locations

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Countries

United States

Other Identifiers

STUDY-24-00641

Identifier Type: -

Identifier Source: org_study_id