Zapping nerves to tame a fluttering heart: new hope for AFib?
NCT ID NCT04529941
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether sending mild electrical pulses just under the skin could help control heart rate in people with atrial fibrillation (AFib). 46 adults with symptomatic paroxysmal AFib who didn't respond to standard drugs were given a device implant. For two weeks, some received active stimulation while others got a sham treatment. Researchers measured changes in AFib burden and heart rate control using mobile heart monitors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- electrical nerve stimulation device
- What this could lead to
- If it works, this could offer a new way to manage atrial fibrillation symptoms without drugs or invasive procedures.
- What could go wrong
- This was a small, early-stage study with only 46 participants. The effect may not be strong or lasting, and not everyone may benefit.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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46 people
The number who actually took part.
- Started
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Nov 2021
- Finished
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Sep 2024
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CedarsSinaiMC
Los Angeles, California, 90048, United States
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