Atrial FibrillationSTALL-AFNCT04529941
Using Electrical Nerve Stimulation to Control Atrial Fibrillation
A study testing Device Implant with Active Treatment and Device Implant without Active Treatment in people with Atrial Fibrillation, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Device Implant with Active Treatment and Device Implant without Active Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Nov 2021to 25 Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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:
- Time-dependent reduction of AF burden
- Effects of ScNS on ventricular rate control during AF
- Reduction of SKNA
- 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.
- Conditions
- Atrial Fibrillation
- Being tested
- Device Implant with Active Treatment, Device Implant without Active Treatment
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device Implant with Active TreatmentDevice
ScNS at 3.5mA output for 2 weeks
Device Implant without Active TreatmentDevice
No device output for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Will receive stimulation ScNS at 3.5mA output Receives: Device: Device Implant with Active Treatment |
| Control Group | Sham comparator | Does not receive therapy Receives: Device: Device Implant without Active Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in AF Burden
Using mobile cardiac telemetry (MCT) to observe if AF burden is lower at 2 Weeks compared to Baseline in the active treatment group than the sham control group
Measured: 2 weeks
Secondary outcomes (4)
Ventricular Rate Control
Improved ventricular rate control during AF.
AF-Free time was separated. Rate control during AF was categorized as the VR <=110 BPM stage.
Measured: 3 Months
Average Skin Sympathetic Nerve Activity (SKNA)
Reduction of SKNA taken from ME6000 (biomonitor) during Six Minute Walk test.
SKNA is sympathetic nerve activity (SNA) recording from a skin-patch electrode used with the ME6000.
Measured: 3 months
Quality of Life - EQ-5D-5L
Improvement of quality of life as measured by the EQ-5D-5L
Measured: 3 months
Quality of Life - AFEQT
Improvement of quality of life as measured by the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) Questionnaire. A score of 0 indicates the most severe symptoms or disability and a score of 100 indicates no limitation or disability. Thus, higher scores on the AFEQT instrument indicate better health status.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start24 Nov 2021
- Primary completion4 Sep 2024
- Study completion25 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana University, National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Peng-Sheng Chen, Cedars-Sinai Medical Center
- Investigators
- Peng-Sheng Chen, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04529941
- Sponsor's protocol ID
- STUDY00000581
- Other IDs
- 7OT2OD028190-02
- Acronym
- STALL-AF
- Status last verified
- Sep 2025
- First submitted
- 25 Aug 2020
- Last updated
- 2 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Electrical Nerve Stimulation to Control Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT04529941
- Acronym / sponsor ID
- STALL-AF / STUDY00000581
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- Indiana University, National Institutes of Health (NIH)
- Study start
- 24 Nov 2021 (actual)
- Primary completion
- 4 Sep 2024 (actual)
- Study completion
- 25 Sep 2024 (actual)
- First posted
- 28 Aug 2020 (actual)
- Results
- Posted 2 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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:
- Time-dependent reduction of AF burden
- Effects of ScNS on ventricular rate control during AF
- Reduction of SKNA
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Device: Device Implant with Active TreatmentWill receive stimulation ScNS at 3.5mA output |
| Control Group | Sham comparator | Device: Device Implant without Active TreatmentDoes not receive therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 to 75 years of age
- Symptomatic Paroxysmal AF.
- 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.
Key exclusion criteria (22 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Device Implant with Active TreatmentScNS at 3.5mA output for 2 weeks | Device | Experimental Group |
| Device Implant without Active TreatmentNo device output for 2 weeks | Device | Control Group |
Primary outcome
Change in AF Burden
Time frame: 2 weeks
Using mobile cardiac telemetry (MCT) to observe if AF burden is lower at 2 Weeks compared to Baseline in the active treatment group than the sham control group
4 secondary outcomes
Ventricular Rate Control
Time frame: 3 Months
Average Skin Sympathetic Nerve Activity (SKNA)
Time frame: 3 months
Quality of Life - EQ-5D-5L
Time frame: 3 months
Quality of Life - AFEQT
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peng-Sheng Chen, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device Implant with Active Treatment and Device Implant without Active Treatment in people with Atrial Fibrillation, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in AF Burden (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.