STALL-AF: Using Electrical Nerve Stimulation to Control Atrial Fibrillation
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
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:
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Time-dependent reduction of AF burden
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Effects of ScNS on ventricular rate control during AF
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Reduction of SKNA
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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 (3.5 mA) for two weeks. The shame group (Group B) will receive sham (0 mA) stimulation for two weeks. The AF burden will be assessed by either a 7-day patch monitor or a mobile cardiac telemetry through a skin patch on the chest wall. The patients will wear an Apple Watch post-procedure to detect any AF episodes within the 3 months post-procedure.
Study duration: 36 Months
Subject duration: up to 4 months. (7 visits, including the procedure day)
Study Design
Arms and Interventions
| 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
Primary Outcome Measures
- AF Burden [2 weeks]
Lower AF burden from Baseline in the active treatment group than the control group
Secondary Outcome Measures
- Ventricular Rate Control [2 weeks]
Improved ventricular rate control during AF
Eligibility Criteria
Criteria
Inclusion Criteria:
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18 to 75 years of age
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Symptomatic AF.
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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.
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There is at least one ECG-documented AF episode within 6 months before signing the consent.
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Unresponsive to conventional therapy is defined by not responding to at least 1 antiarrhythmic drug (class I, class III, or atrioventricular nodal blocker).
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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 recorded on the eligibility visit 7 day continuous rhythm recording
Exclusion Criteria:
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Patients without AF episodes during monitoring period will be excluded from the study and count as screen failure
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Left ventricular ejection fraction <40%
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Heart failure with functional classes III or IV
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Recurrent vasovagal syncope
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Valvular AF (severe mitral regurgitation, mitral stenosis)
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Congenital heart diseases
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Wolff Parkinson-White Syndrome
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Stroke within the past 6 months
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Any history of myocardial infarction
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Malignancies with a life expectancy of < 1 year
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A history of ablation procedures to treat left atrial tachyarrhythmias or other serious comorbidity
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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.
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Patients with a vagal nerve stimulator
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Active thyrotoxicosis
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Sick sinus syndrome with symptomatic bradycardia
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Heart rate < 50 beats per minute in sinus rhythm on 12-lead ECG
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Systolic blood pressure < 90 mm Hg
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Any experimental medication concomitantly or within 4 weeks of participation in the study
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Subjects with cardiac implantable electronic device (CIED) such as pacemakers and implantable cardioverter-defibrillators (ICDs)
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Pre-existing neuromodulation devices, such as vagal nerve stimulators, spinal cord stimulators and sacral nerve stimulators
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People with a history of allergy to ECG electrodes, adhesive tape, nylon or latex
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Pregnant women
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CedarsSinaiMC | Los Angeles | California | United States | 90048 |
Sponsors and Collaborators
- Cedars-Sinai Medical Center
- Indiana University
Investigators
- Principal Investigator: Peng-Sheng Chen, MD, Cedars-Sinai Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY00000581