Using Electrical Nerve Stimulation to Control Atrial Fibrillation

NCT04529941 | Completed Results DMC FDA Device

• 2 other identifiers: STUDY000005817OT2OD028190-02
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine if sending mild electrical signals just under your skin will improve atrial fibrillation symptoms by controlling your heart rate.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Change in AF Burden

  Using mobile cardiac telemetry (MCT) to observe if AF burden is lower at 2 Weeks compared to Baseline in the active treatment group than the sham control group

  2 weeks

Secondary Outcomes (4)

• Ventricular Rate Control

  3 Months

• Average Skin Sympathetic Nerve Activity (SKNA)

  3 months

• Quality of Life - EQ-5D-5L

  3 months

• Quality of Life - AFEQT

  3 months

Study Arms (2)

Experimental Group

EXPERIMENTAL

Will receive stimulation ScNS at 3.5mA output

Device: Device Implant with Active Treatment

Control Group

SHAM COMPARATOR

Does not receive therapy

Device: Device Implant without Active Treatment

Interventions

Device Implant with Active Treatment DEVICE

ScNS at 3.5mA output for 2 weeks

Experimental Group

Device Implant without Active Treatment DEVICE

No device output for 2 weeks

Control Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 75 years of age
• Symptomatic Paroxysmal AF.
• Symptomatic paroxysmal AF is defined by AF with patient-reported perception of one or more of the following symptoms: palpitations, dizziness/presyncope, syncope, dyspnea, chest pain, malaise, and fatigue and activity intolerance.
• There is at least one ECG-documented AF episode.
• Unresponsive to conventional therapy is defined by not responding to at least 1 antiarrhythmic drug (class I, class III, or atrioventricular nodal blocker).
• The left atrial size \<50 mm by transthoracic echocardiography documented by eligibility visit echocardiogram
• Documented atrial fibrillation as defined as atrial fibrillation \>30 seconds in duration with an atrial fibrillation burden determined by a minimum of 7 days of continuous ePatch monitoring within 6 months before surgery.

You may not qualify if:

• Patients without AF episodes during monitoring period will be excluded from the study and count as screen failure
• Left ventricular ejection fraction \<40%
• Heart failure with functional classes III or IV
• Recurrent vasovagal syncope
• Valvular AF (severe mitral regurgitation, mitral stenosis)
• Congenital heart diseases
• Wolff Parkinson-White Syndrome
• Stroke within the past 6 months
• Any history of myocardial infarction
• Malignancies with a life expectancy of \< 1 year
• A history of ablation procedures to treat left atrial tachyarrhythmias or other serious comorbidity
• Any history of sustained ventricular tachycardia (VT) defined by (1) \> 30 s in duration or (2) \< 30 s in duration, but is associated with hemodynamic consequences such as hypotension and syncope.
• Patients with a vagal nerve stimulator
• Active thyrotoxicosis
• Sick sinus syndrome with symptomatic bradycardia

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• Indiana University: collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

CedarsSinaiMC

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Equipment and Supplies

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Peng-Sheng Chen
• Organization: Cedars-Sinai Medical Center

Peng-Sheng.Chen@cshs.org

310-967-2707

Study Officials

• Peng-Sheng Chen, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Subjects will not be aware whether the ScNS is turned on or off. However, after three weeks from the initial surgery, control subjects that decide to the second procedure will be aware of what group they were randomized to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Model Details: Patients will have a 1:1 randomization to receive subcutaneous electrical nerve stimulation (ScNS) to observe if the stimulation can reduce atrial fibrillation burden in patients with symptomatic atrial fibrillation (AF). All subjects will undergo the implant of a neurostimulator lead. The experimental group will receive stimulation and the control group will not receive stimulation. All subjects will complete the same follow up visits comparing the 2 groups. The control group will have an option to cross over to the experimental group 3 weeks post-randomization to receive the stimulation. They will repeat the baseline visit, procedure visit and all follow-up visits post-procedure.

Study Record Dates

• First Submitted: August 25, 2020
• First Posted: August 28, 2020
• Study Start: November 24, 2021
• Primary Completion: September 4, 2024
• Study Completion: September 25, 2024
• Last Updated: October 2, 2025
• Results First Posted: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)