Atrial FibrillationNEUROPULSENCT06748157
Non-Invasive Median Nerve Stimulation to Attenuate Atrial Tachyarrhythmias After Catheter Ablation for Atrial Fibrillation
A study testing CardiaCare RR2 in people with Atrial Fibrillation, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
Determine the role of vagal/median nerve stimulation using the CardiaCare RR2 home care wearable neuromodulation system on suppressing atrial arrhythmias and related symptoms in patients who have undergone AF ablation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- CardiaCare RR2
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2024to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women ages ≥18 years
- Patients planned to undergo or undergoing AF ablation for paroxysmal or persistent AF and able to be randomized within 48 hours of the ablation procedure.
- Ability and willingness to sign an informed consent form.
- Ability and willingness to use CardiaCare RR2 device, continuous ECG monitoring, and has an available SmartPhone.
Who cannot join
- Rheumatic heart disease
- Extensive atrial disease (* some patients may be determined to be screen failures following the ablation procedure).
- Moderate to severe mitral stenosis or history of mitral valve replacement
- Pacemaker or CRTD or any implanted electrical stimulating device
- Unilateral or bilateral vagotomy
- Peripheral neuropathy affecting the tested upper extremity.
Show all 13Show fewer
- Severe heart failure (New York Heart Association Class III or IV) within 90 days.
- Recent (within 90 days) stroke or transient ischemic attack.
- Recent (within 90 days) myocardial infarction.
- Pregnancy or breast feeding.
- Life expectancy <1 year for any medical condition
- Currently enrolled in another study that would interfere with this study
- Unsuitable for participating in the study according to attending physician
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Determine the role of vagal/median nerve stimulation using the CardiaCare RR2 home care wearable neuromodulation system on suppressing atrial arrhythmias and related symptoms in patients who have undergone AF ablation. The study population will be comprised of adults (age ≥18 yrs.) who have undergone AF ablation for paroxysmal or persistent AF.
The study will assess the ability of neuromodulation, using the CardiaCare RR2 home care wearable, to suppress the following:
Read more
- early (0-2 months) post-ablation arrhythmias that occur in the immediate post-ablation time period
- AF/AT/AFL recurrences between months 2-6 post-ablation.This is a prospective, controlled, double-blind, randomized trial. The first 15 patients will not be randomized and will receive the active median/vagal stimulation only (open label).
The Study will be conducted in up to 1 clinical site in the United States. This study will have 1:1 randomization (active median/vagal stimulation vs sham). The study has been given NSR designation from FDA--NO IDE.
Read the detailed description
Study will include continuous ECG assessment at 2 (0 for the first 15 patients, open label), 6 and 22 weeks from enrollment for 2 weeks (for 4 weeks at the first measurement for the first 15 patients, open label) and at least daily single lead ECG assessments throughout the follow up period. The ECG's generated can be viewed by physicians only to assess the frequency of RR2 treatments and will not be used to alter any other aspects of standard of care, including medical management, which will continue according to standard of care throughout the study. Patients and investigators will be blinded during the trial. Patients with paroxysmal or persistent AF undergoing AF ablation will be recruited post ablation procedure during hospitalization. During screening/baseline visit, eligible patients will be randomized to either an active treatment or a sham group (1:1 accordingly). The first 15 eligible patients will not be randomized and will receive the active median/vagal stimulation only (open label).
Patients will receive training on the RR2 for home-care use, by study personnel either in person or via a video conference meeting. An instructional video will also be available for users. Patients will be ordered to measure at home, 2 min ECG measurements with the RR2 system, two times a day throughout the study and when feeling symptoms suspected related to AF (AF/AT/PAC).
In addition, Patients will be instructed to perform Neuromodulation sessions with the RR2 home care device. Once a day for the first 2 weeks followed by three times per week for the remaining duration of the study. Additional treatments, up to once daily, will be added during this period in case the patient feels symptom, verified on single lead ECG and site staff.
Treatments will be conducted for a period of 6 months. During the study, the patients will continue to take Standard of care medication. Medications will be recorded throughout the study.
Patient Diary will be dispensed and or APP diary questioners will be used by the subject in order to document symptoms suspected as related to arrhythmia events.
- Conditions
- Atrial Fibrillation
- Being tested
- CardiaCare RR2, Sham Device
- Keywords
- AFib, Neuromodulation, Prevent AFib
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardiaCare RR2Device
CardiaCare has developed a wrist band that delivers non-invasive neuromodulation to the median nerve to elicit a vagal response (Median-Vagus nerve stimulation-mVNS). The device is in the post-prototype development stage and is ready for human clinical trials. The CardiaCare RR2 device has already been approved by the IRB of the Chaim Sheba Medical Center, IL and the IL MOH (Ministry of Health) in an already completed pilot clinical trial for modulating AF.
Sham DeviceDevice
Sham device will be dispensed, which will create a sensation but not provide therapy
| Study group | Role | What they receive |
|---|---|---|
| Participants with CardiaCare RR2 | Active comparator | Participants undergoing Neuromodulation Sessions (mNVS) and Active Median/Vagal Stimulation. Patients will receive training on the RR2 for home-care use, by study personnel either in person or via a video conference meeting. An instructional video will also be available for users. Receives: Device: CardiaCare RR2 |
| Participants with Sham Device | Sham comparator | Sham device will be dispensed, which will create a sensation but not provide therapy Receives: Device: Sham Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
AF/AFL occurrence
Burden of AF/AFL (defines as 30 seconds or longer) during the 2-months and 6-months period after ablation measured using ECG-patch monitoring and daily RR2 single lead ECG.
Measured: at 2-months and 6-months post-ablation procedure
Secondary outcomes (12)
Time to first Atrial tachycardia (AT) or Atrial Fibrillation (AF) recurrence
Time to first AT or AF recurrence measured by CardiaCare RR2
Measured: 2-month and 6-month post-ablation procedure
Number of arrythmia occurrences
Burden of all arrythmias between 2- and 6-months period after ablation will be measured using 2 weeks ECG-patch monitoring and daily RR2 single lead ECG.
Measured: 2-month and 6-month post-ablation procedure
Number of Atrial Arrythmia Symptoms
Difference in Atrial Arrythmia Symptoms during the 6 months period after ablation.
Measured: 6-month post-ablation procedure
Time to first Atrial tachycardia (AT) or Atrial Fibrillation (AF) recurrence
Time to first Atrial tachycardia (AT) or Atrial Fibrillation (AF) recurrence during the 6-months period after ablation.
Measured: 6 months post-ablation
Quality of Life measured using The European Heart Rhythm Association (EHRA) score
The investigators will assess the change in EHRA symptom scale. The EHRA score ranges from 1 to 4. Higher scores indicate more severe symptoms.
Measured: Baseline, 2-months, and 6-months
Quality of Life measured using Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) Score
The AFEQT is a questionnaire assessing quality of life and symptoms in atrial fibrillation patients. It covers four subscales: patient symptoms, daily activities, treatment concerns, and treatment satisfaction. Subscales from 0-100, with Full Scale range from 0 to 100, with higher scores indicating better quality of life and fewer symptom burdens.
Measured: Baseline, 2-months, and 6-months
Change in PAC/AT/AFL before and after treatment with RR2
Change, such as increase or decrease, in incidence/frequency of atrial arrhythmias before and after treatment with study device.
Measured: Baseline and 6-month post-ablation
Change in Heart Rate Variability (HRV)
Heart rate variability (HRV) is the variation in the time interval between consecutive heartbeats. Higher HRV indicates better cardiovascular function and stress resilience.
Measured: Baseline and 6-month post-ablation
Number of ER Visits
Measured: 6-month post-ablation
Number of Hospitalizations
Measured: 6-month post-ablation
Number of Cardioversions
Measured: 6-month post-ablation
Number of Ablation Re-Do's
Measured: 6-month post-ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start2 Oct 2024
- Primary completion14 Aug 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 randomization
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Ziv HealthCare Ltd.
- Responsible party
- Principal investigator, Vivek Reddy, Icahn School of Medicine at Mount Sinai
- Investigators
- Vivek Reddy, MD, Principal investigator, Icahn School of Medicine at Mount SinaiMohit Turagam, MD, Principal investigator, Icahn School of Medicine at MS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06748157
- Sponsor's protocol ID
- STUDY-24-00641
- Acronym
- NEUROPULSE
- Status last verified
- Jul 2026
- First submitted
- 19 Dec 2024
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Reddy VY, Nair DG, Turagam MK, Rosso R, Banai A, Henriques L, Strzeciwilk M, Schwartz N, Holand T, Benari A, Puzhevsky D, Ziv A, Chorin E. Noninvasive median nerve stimulation with a wearable stimulator to reduce atrial arrhythmia recurrence after atrial fibrillation ablation: The NEUROPULSE pilot. Heart Rhythm. 2026 Sep 20:S1547-5271(26)02777-3. doi: 10.1016/j.hrthm.2026.09.013. Online ahead of print.
PubMed 42764112
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Median Nerve Stimulation to Attenuate Atrial Tachyarrhythmias After Catheter Ablation for Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT06748157
- Acronym / sponsor ID
- NEUROPULSE / STUDY-24-00641
- Conditions
- Atrial Fibrillation
- Keywords
- AFib, Neuromodulation, Prevent AFib
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Ziv HealthCare Ltd.
- Study start
- 2 Oct 2024 (actual)
- Primary completion
- 14 Aug 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 27 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Determine the role of vagal/median nerve stimulation using the CardiaCare RR2 home care wearable neuromodulation system on suppressing atrial arrhythmias and related symptoms in patients who have undergone AF ablation. The study population will be comprised of adults (age ≥18 yrs.) who have undergone AF ablation for paroxysmal or persistent AF.
The study will assess the ability of neuromodulation, using the CardiaCare RR2 home care wearable, to suppress the following:
- early (0-2 months) post-ablation arrhythmias that occur in the immediate post-ablation time period
- AF/AT/AFL recurrences between months 2-6 post-ablation.This is a prospective, controlled, double-blind, randomized trial. The first 15 patients will not be randomized and will receive the active median/vagal stimulation only (open label).
The Study will be conducted in up to 1 clinical site in the United States. This study will have 1:1 randomization (active median/vagal stimulation vs sham). The study has been given NSR designation from FDA--NO IDE.
Detailed description
Study will include continuous ECG assessment at 2 (0 for the first 15 patients, open label), 6 and 22 weeks from enrollment for 2 weeks (for 4 weeks at the first measurement for the first 15 patients, open label) and at least daily single lead ECG assessments throughout the follow up period. The ECG's generated can be viewed by physicians only to assess the frequency of RR2 treatments and will not be used to alter any other aspects of standard of care, including medical management, which will continue according to standard of care throughout the study. Patients and investigators will be blinded during the trial. Patients with paroxysmal or persistent AF undergoing AF ablation will be recruited post ablation procedure during hospitalization. During screening/baseline visit, eligible patients will be randomized to either an active treatment or a sham group (1:1 accordingly). The first 15 eligible patients will not be randomized and will receive the active median/vagal stimulation only (open label).
Patients will receive training on the RR2 for home-care use, by study personnel either in person or via a video conference meeting. An instructional video will also be available for users. Patients will be ordered to measure at home, 2 min ECG measurements with the RR2 system, two times a day throughout the study and when feeling symptoms suspected related to AF (AF/AT/PAC).
In addition, Patients will be instructed to perform Neuromodulation sessions with the RR2 home care device. Once a day for the first 2 weeks followed by three times per week for the remaining duration of the study. Additional treatments, up to once daily, will be added during this period in case the patient feels symptom, verified on single lead ECG and site staff.
Treatments will be conducted for a period of 6 months. During the study, the patients will continue to take Standard of care medication. Medications will be recorded throughout the study.
Patient Diary will be dispensed and or APP diary questioners will be used by the subject in order to document symptoms suspected as related to arrhythmia events.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 1:1 randomization
| Arm | Type | Receives |
|---|---|---|
| Participants with CardiaCare RR2 | Active comparator | Device: CardiaCare RR2Participants undergoing Neuromodulation Sessions (mNVS) and Active Median/Vagal Stimulation. Patients will receive training on the RR2 for home-care use, by study personnel either in person or via a video conference meeting. An instructional video will also be available for users. |
| Participants with Sham Device | Sham comparator | Device: Sham DeviceSham device will be dispensed, which will create a sensation but not provide therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women ages ≥18 years
- Patients planned to undergo or undergoing AF ablation for paroxysmal or persistent AF and able to be randomized within 48 hours of the ablation procedure.
- Ability and willingness to sign an informed consent form.
- Ability and willingness to use CardiaCare RR2 device, continuous ECG monitoring, and has an available SmartPhone.
Key exclusion criteria (13 listed)
- Rheumatic heart disease
- Extensive atrial disease (* some patients may be determined to be screen failures following the ablation procedure).
- Moderate to severe mitral stenosis or history of mitral valve replacement
- Pacemaker or CRTD or any implanted electrical stimulating device
- Unilateral or bilateral vagotomy
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 |
|---|---|---|
| CardiaCare RR2CardiaCare has developed a wrist band that delivers non-invasive neuromodulation to the median nerve to elicit a vagal response (Median-Vagus nerve stimulation-mVNS). The device is in the post-prototype development stage and is ready for human clinical trials. The CardiaCare RR2 device has already been approved by the IRB of the Chaim Sheba Medical Center, IL and the IL MOH (Ministry of Health) in an already completed pilot clinical trial for modulating AF. | Device | Participants with CardiaCare RR2 |
| Sham DeviceSham device will be dispensed, which will create a sensation but not provide therapy | Device | Participants with Sham Device |
Primary outcome
AF/AFL occurrence
Time frame: at 2-months and 6-months post-ablation procedure
Burden of AF/AFL (defines as 30 seconds or longer) during the 2-months and 6-months period after ablation measured using ECG-patch monitoring and daily RR2 single lead ECG.
12 secondary outcomes
Time to first Atrial tachycardia (AT) or Atrial Fibrillation (AF) recurrence
Time frame: 2-month and 6-month post-ablation procedure
Number of arrythmia occurrences
Time frame: 2-month and 6-month post-ablation procedure
Number of Atrial Arrythmia Symptoms
Time frame: 6-month post-ablation procedure
Time to first Atrial tachycardia (AT) or Atrial Fibrillation (AF) recurrence
Time frame: 6 months post-ablation
Quality of Life measured using The European Heart Rhythm Association (EHRA) score
Time frame: Baseline, 2-months, and 6-months
Quality of Life measured using Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) Score
Time frame: Baseline, 2-months, and 6-months
Change in PAC/AT/AFL before and after treatment with RR2
Time frame: Baseline and 6-month post-ablation
Change in Heart Rate Variability (HRV)
Time frame: Baseline and 6-month post-ablation
Number of ER Visits
Time frame: 6-month post-ablation
Number of Hospitalizations
Time frame: 6-month post-ablation
Number of Cardioversions
Time frame: 6-month post-ablation
Number of Ablation Re-Do's
Time frame: 6-month post-ablation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Derived from this study: PubMed 42764112Reddy VY, Nair DG, Turagam MK, Rosso R, Banai A, Henriques L, Strzeciwilk M, Schwartz N, Holand T, Benari A, Puzhevsky D, Ziv A, Chorin E. Noninvasive median nerve stimulation with a wearable stimulator to reduce atrial arrhythmia recurrence after atrial fibrillation ablation: The NEUROPULSE pilot. Heart Rhythm. 2026 Sep 20:S1547-5271(26)02777-3. doi: 10.1016/j.hrthm.2026.09.013. Online ahead of print.
- Individual participant dataSharing planned: No
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Atrial Fibrillation (AF)
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.
Vivek Reddy, MD principal investigator
Icahn School of Medicine at Mount Sinai
Mohit Turagam, MD principal investigator
Icahn School of Medicine at MS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CardiaCare RR2 in people with Atrial Fibrillation, run by Icahn School of Medicine at Mount Sinai 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 4 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 21 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
AF/AFL occurrence (time frame: at 2-months and 6-months post-ablation procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06748157, which also lists 1 linked publication.
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 21 Jul 2026.