Using Electrical Nerve Stimulation to Control Atrial Fibrillation (STALL-AF)

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: Device Implant with Active Treatment; Device: Device Implant without Active Treatment

Detailed Description

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 to compare the 2 groups.

Primary Objective: To test the hypothesis that chronic subcutaneous nerve stimulation can reduce AF burden in patients with severe symptomatic AF unresponsive to conventional therapies

The secondary objective:

To test the hypotheses that the effect of ScNS on the following endpoints is different between the two randomization groups:

1. Time-dependent reduction of AF burden
2. Effects of ScNS on ventricular rate control during AF
3. Reduction of SKNA
4. Improvement of quality of life

The study will enroll patients with symptomatic atrial fibrillation unresponsive to conventional therapy defined by not responding to at least 1 antiarrhythmic drug. The study will enroll 30 patients, including 15 men and 15 women between the 18 and 75 years old. There will be no sex/gender/racial/ethnic based exclusion. Patients will be enrolled from the Cedars Sinai Medical Center.

The patients will undergo surgical implantation of an externalized lead under the skin on the chest wall. The wire is then connected to a neurostimulator. The experimental group (Group A) will receive ScNS (3.5mA) for two weeks. The sham group (Group B) will receive sham (0 mA) stimulation for two weeks. The AF burden will be assessed by a 7-day mobile cardiac telemetry device provided by Preventice. An additional mobile cardiac telemetry device, Bittium Faros, will also be worn at similar time points to monitor skin sympathetic nerve activity. An Apple watch will be used to collect additional information on the frequencies of AF between the Baseline Visit until the 3 Month Visit 7 Day Mobile Cardiac Telemetry is complete. After completion of the week 3 visit, the sham group (Group B) will be able to receive ScNS (3.5 mA) for two weeks. The AF burden will be assessed post-procedure by mobile cardiac telemetry by Preventice and Bittium Faros

Study duration: 36 Months

Subject duration: up to 5 months.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Peng-Sheng Chen, MD; Phone Number: 310-423-6084; Email: Chenp@cshs.org
• Study Contact Backup: Name: Tracey S Early, BS, MA; Phone Number: 310.423.1231; Email: tracey.early@cshs.org

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Recruiting
      • CedarsSinaiMC
      • Contact: Anxhela Kote, BS; Phone Number: 310-967-3854; Email: anxhela.kote@cshs.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 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.

Exclusion Criteria:

• 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
• Heart rate < 50 beats per minute in sinus rhythm on 12-lead ECG
• Systolic blood pressure < 90 mm Hg
• Any experimental medication concomitantly or within 4 weeks of participation in the study
• Subjects with cardiac implantable electronic device (CIED) such as pacemakers and implantable cardioverter-defibrillators (ICDs)
• Pre-existing neuromodulation devices, such as vagal nerve stimulators, spinal cord stimulators and sacral nerve stimulators
• People with a history of allergy to ECG electrodes, adhesive tape, or nylon
• Pregnant women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; Will receive stimulation ScNS at 3.5mA output	Device: Device Implant with Active Treatment; ScNS at 3.5mA output for 2 weeks
Sham Comparator: Control Group; Does not receive therapy	Device: Device Implant without Active Treatment; No device output for 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AF Burden	Lower AF burden from Baseline in the active treatment group than the control group	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ventricular Rate Control	Improved ventricular rate control during AF	2 weeks

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Collaborators: National Institutes of Health (NIH); Indiana University
• Investigators: Principal Investigator: Peng-Sheng Chen, MD, Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2021
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: August 25, 2020
• First Submitted That Met QC Criteria: August 25, 2020
• First Posted (Actual): August 28, 2020

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: STUDY00000581; 7OT2OD028190-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes