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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04529941
Recruitment Status : Recruiting
First Posted : August 28, 2020
Last Update Posted : November 21, 2022
Sponsor:
Collaborator:
Indiana University
Information provided by (Responsible Party):
Peng-Sheng Chen, Cedars-Sinai Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Device: Device Implant with Active Treatment Device: Device Implant without Active Treatment Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model 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 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.
Masking: Single (Participant)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Using Electrical Nerve Stimulation to Control Atrial Fibrillation
Actual Study Start Date : November 24, 2021
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. AF Burden [ Time Frame: 2 weeks ]
    Lower AF burden from Baseline in the active treatment group than the control group


Secondary Outcome Measures :
  1. Ventricular Rate Control [ Time Frame: 2 weeks ]
    Improved ventricular rate control during AF


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 to 75 years of age

  • Symptomatic AF.

    • Symptomatic 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, nylon or latex
  • Pregnant women
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04529941


Contacts
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Contact: Peng-Sheng Chen, MD 310-423-6084 Chenp@cshs.org
Contact: Tracey S Early, BS, MA 310.423.1231 tracey.early@cshs.org

Locations
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United States, California
CedarsSinaiMC Recruiting
Los Angeles, California, United States, 90048
Contact: Jewel Reaso, BS    310-967-3854      
Sponsors and Collaborators
Cedars-Sinai Medical Center
Indiana University
Investigators
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Principal Investigator: Peng-Sheng Chen, MD Cedars-Sinai Medical Center
More Information
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Responsible Party: Peng-Sheng Chen, Staff Physician, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT04529941    
Other Study ID Numbers: STUDY00000581
First Posted: August 28, 2020    Key Record Dates
Last Update Posted: November 21, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes