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

Not Applicable

Active, not recruiting

• Conditions: Atrial Fibrillation

• Registration Number: NCT06748157
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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.

Study Timeline

• Study Start: 2024-10-02
• Study First Submitted: 2024-12-19
• Study First Submitted QC: 2024-12-19
• Study First Posted: 2024-12-27
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-02
• Last Update Posted: 2025-05-06
• Primary Completion: 2026-04
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
AF/AFL occurrence	at 2-months and 6-months post-ablation procedure	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.

Secondary Outcome Measures

Name	Time	Method
Time to first Atrial tachycardia (AT) or Atrial Fibrillation (AF) recurrence	6 months post-ablation	Time to first Atrial tachycardia (AT) or Atrial Fibrillation (AF) recurrence during the 6-months period after ablation.
Number of arrythmia occurrences	2-month and 6-month post-ablation procedure	Burden of all arrythmias between 2- and 6-months period after ablation will be measured using 2 weeks ECG-patch monitoring and daily RR2 single lead ECG.
Number of Atrial Arrythmia Symptoms	6-month post-ablation procedure	Difference in Atrial Arrythmia Symptoms during the 6 months period after ablation.
Quality of Life measured using The European Heart Rhythm Association (EHRA) score	Baseline, 2-months, and 6-months	The investigators will assess the change in EHRA symptom scale. The EHRA score ranges from 1 to 4. Higher scores indicate more severe symptoms.
Quality of Life measured using Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) Score	Baseline, 2-months, and 6-months	The AFEQT is a questionnaire assessing quality of life and symptoms in atrial fibrillation patients. It covers four subscales: patient symptoms, daily activities, treatment concerns, and treatment satisfaction. Subscales from 0-100, with Full Scale range from 0 to 100, with higher scores indicating better quality of life and fewer symptom burdens.
Change in PAC/AT/AFL before and after treatment with RR2	Baseline and 6-month post-ablation	Change, such as increase or decrease, in incidence/frequency of atrial arrhythmias before and after treatment with study device.
Change in Heart Rate Variability (HRV)	Baseline and 6-month post-ablation	Heart rate variability (HRV) is the variation in the time interval between consecutive heartbeats. Higher HRV indicates better cardiovascular function and stress resilience.
Number of ER Visits	6-month post-ablation
Number of Hospitalizations	6-month post-ablation
Number of Cardioversions	6-month post-ablation
Number of Ablation Re-Do's	6-month post-ablation

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States