N/A
N=16
Using Electrical Nerve Stimulation to Control Atrial Fibrillation
Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT04529941 ↗Enrolled (actual)
16
Serious AEs
5.9%
Results posted
Oct 2025
Primary outcome: Primary: Change in AF Burden — -0.4; -2.4 percentage of time in AF
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Device Implant with Active Treatment (Device); Device Implant without Active Treatment (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cedars-Sinai Medical Center
- Primary completion
- Sep 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in AF Burden |
-0.4; -2.4 | — |
| SECONDARY Ventricular Rate Control |
0; 0; 4; 4; 2; 2 | — |
| SECONDARY Average Skin Sympathetic Nerve Activity (SKNA) |
0.93; 1.12; 0.89; 0.85; 2.15; 1.65 | — |
| SECONDARY Quality of Life - EQ-5D-5L |
7.7; 6.3; 7.2; 6.2; 9.3; 6.0 | — |
| SECONDARY Quality of Life - AFEQT |
65.7; 49.7; 61.6; 63.1; 63.9; 71.7 | — |
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.
Eligibility Criteria
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 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 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
Data sourced from ClinicalTrials.gov (NCT04529941). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.