Status:
COMPLETED
Using Electrical Nerve Stimulation to Control Atrial Fibrillation
Lead Sponsor:
Cedars-Sinai Medical Center
Collaborating Sponsors:
Indiana University
National Institutes of Health (NIH)
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-75 years
Phase:
NA
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.
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 atri...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 25 2024
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT04529941
Start Date
November 24 2021
End Date
September 25 2024
Last Update
October 2 2025
Active Locations (1)
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1
CedarsSinaiMC
Los Angeles, California, United States, 90048