CardiaCare Device for Atrial Fibrillation

(NEUROPULSE Trial)

Overseen By Betsy Ellsworth, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Rheumatic heart disease, Severe heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a wearable device, CardiaCare RR2, might reduce irregular heartbeats in individuals who have undergone an ablation procedure for atrial fibrillation (AF). The device uses neuromodulation, stimulating certain nerves to potentially calm the heart's rhythm, specifically through non-invasive median nerve stimulation. Participants will use either the actual device or a sham version that mimics the sensation without providing therapy. This trial suits adults who have recently had an AF ablation and are willing to use the device and a smartphone app for monitoring. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance future AF treatment options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that the CardiaCare device is safe for atrial fibrillation patients?

Research has shown that non-invasive median nerve stimulation (MNS) is generally safe. Studies have found that MNS does not significantly increase the risk of issues like seizures or heightened heart activity. These studies suggest that side effects such as irregular heartbeat and nausea are uncommon. Initial results appear promising, but further research is needed to fully understand its effects on heart rhythm. Overall, MNS is well-tolerated, with few reports of serious side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CardiaCare Device for atrial fibrillation because it offers a novel, non-invasive approach: median nerve stimulation. Unlike standard treatments like antiarrhythmic drugs or catheter ablation, this device uses neuromodulation to potentially regulate heart rhythms without surgery or medication side effects. This method could provide a safer, more accessible option for patients, allowing them to manage their condition at home with user-friendly training and support. This innovative approach could transform how atrial fibrillation is managed, offering hope for effective, non-invasive treatment.

What evidence suggests that the CardiaCare device is effective for atrial fibrillation?

Research has shown that non-invasive median nerve stimulation (MNS), which participants in this trial may receive through the CardiaCare RR2 device, positively affects heart rhythms. Studies have found that this stimulation helps manage irregular heartbeats, known as atrial arrhythmias, by reducing episodes and improving heart rate consistency. This method, called neuromodulation, alters nerve activity to stabilize heart signals. It targets the nerves connected to the heart to reduce the recurrence of atrial fibrillation (AF). Early results are promising and suggest it may decrease irregular heartbeats after AF treatment. ^{1 6 7 8 9}

Who Is on the Research Team?

Mohit Turagam, MD

Principal Investigator

Icahn School of Medicine at MS

Vivek Reddy, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

Adults (age ≥18 yrs.) who have undergone catheter ablation for paroxysmal or persistent atrial fibrillation. Participants must be in the post-ablation period, either early (0-2 months) or between months 2-6. Specific inclusion and exclusion criteria details are not provided.

Inclusion Criteria

I am scheduled for or have had AF ablation and can join a study within 2 days of the 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

Exclusion Criteria

Unsuitable for participating in the study according to attending physician

I have had surgery to cut the nerves to my stomach.

I have nerve damage in my arm that was tested.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person or virtual)

Treatment

Participants receive neuromodulation using the CardiaCare RR2 home care wearable for 6 months

6 months

Continuous home monitoring with periodic in-person or virtual check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person or virtual)

Open-label extension (optional)

First 15 patients receive open-label active median/vagal stimulation

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Non-Invasive Median Nerve Stimulation

Trial Overview The trial is testing a wearable neuromodulation system called CardiaCare RR2 to see if it can prevent arrhythmias after AF ablation. It's a controlled study where patients are randomly assigned to get either real stimulation or a sham device.

How Is the Trial Designed?

Group I: Participants with CardiaCare RR2 Active Control 1 Intervention

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.

Group II: Participants with Sham Device Placebo Group 1 Intervention

Sham device will be dispensed, which will create a sensation but not provide therapy

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Ziv HealthCare Ltd.

Industry Sponsor

Trials

3

Recruited

130+

Published Research Related to This Trial

Subcutaneous nerve stimulation (ScNS) significantly reduced stellate ganglion nerve activity and improved ventricular rate control in dogs with persistent atrial fibrillation (AF), lowering the mean ventricular rate from 149 to 84 beats per minute.

ScNS also preserved left ventricular ejection fraction compared to the sham control group, indicating its potential for beneficial neural remodeling in the brain stem and stellate ganglia during AF treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subcutaneous nerve stimulation for rate control in ambulatory dogs with persistent atrial fibrillation. Yuan, Y., Liu, X., Wan, J., et al.[2020]

Chronic median nerve stimulation (MNS) significantly reduced the occurrence of ventricular arrhythmias in rabbits post-myocardial infarction, with fewer premature ventricular complexes and episodes of ventricular tachycardia compared to the control group.

MNS also improved left ventricular function, as indicated by a higher ejection fraction, and decreased levels of sympathetic nerve density and inflammatory markers, suggesting that its protective effects may be due to reduced sympathetic activity and anti-inflammatory actions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic median nerve modulation reduces ventricular arrhythmia and improves ventricular function in a postmyocardial infarction rabbit model. Zhai, Z., Zhao, S., Tang, M., et al.[2018]

Nonpharmacologic treatments for atrial fibrillation (AF), such as electrical cardioversion and radiofrequency catheter ablation, are essential for restoring sinus rhythm, especially when medications fail, and anticoagulation is crucial for virtually all patients.

In chronic AF cases, internal atrial defibrillation has shown feasibility and efficacy, suggesting that advanced nonpharmacologic interventions may be necessary when conventional treatments are ineffective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonpharmacologic strategies for treating atrial fibrillation. Lüderitz, B., Pfeiffer, D., Tebbenjohanns, J., et al.[2019]

The development of an implantable atrial defibrillator shows promise as a new treatment option for patients with recurrent atrial fibrillation, supported by advances in device technology and the feasibility of low-energy internal cardioversion.

Preliminary data indicate that low-energy shocks for atrial defibrillation are safe and do not lead to dangerous ventricular arrhythmias, but further clinical evaluation is needed to determine the best patient candidates and treatment protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The future role of defibrillators in the management of atrial fibrillation. Ayers, GM., Griffin, JC.[2019]

Current antiarrhythmic drug therapies for atrial fibrillation have limited effectiveness and can pose risks, prompting the exploration of various alternative treatments, including implantable defibrillators and catheter ablation.

While these new interventional therapies show promise, they each have significant limitations, such as invasiveness, variable efficacy, and risks of complications, indicating a need for further research and technological advancements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonpharmacologic therapies for atrial fibrillation. Keane, D., Zou, L., Ruskin, J.[2019]

A new wireless implantable system for stimulating and monitoring ECG has been developed specifically for the rapid atrial pacing model, which is widely used in atrial fibrillation research.

This system has been successfully tested in both in-vitro simulations and in-vivo animal models, allowing for real-time initiation and monitoring of chronic atrial fibrillation, enhancing research capabilities in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A wireless implantable stimulating and ECG monitoring system for animal models of chronic atrial fibrillation]. Jin, X., Zhang, W., Li, Y., et al.[2018]

A novel cardioneuroablation technique using pulsed electric field energy targets the cardiac autonomic nervous system to potentially treat atrial fibrillation (AF), which affects millions globally.

Early clinical and pre-clinical studies suggest that this technique effectively modulates the ANS structures on the heart's surface, offering a new approach to managing AF.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardioneuroablation Using Epicardial Pulsed Field Ablation for the Treatment of Atrial Fibrillation. O'Brien, B., Reilly, J., Coffey, K., et al.[2023]

In a study of 72 patients with sick sinus syndrome and atrial fibrillation, the AF prevention algorithm significantly increased atrial pacing from 78.7% to 92.4%, indicating improved pacing consistency.

Despite the increase in atrial pacing, the algorithm did not affect the number of automatic mode switches in either unipolar or bipolar pacing modes, suggesting that while the algorithm enhances pacing, it does not necessarily prevent episodes of atrial fibrillation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dynamic and dual-site atrial pacing in the prevention of atrial fibrillation: The STimolazione Atrial DInamica Multisito (STADIM) Study. De Simone, A., Senatore, G., Donnici, G., et al.[2008]

Atrial fibrillation in patients with heart failure is linked to higher mortality and more hospitalizations, but restoring normal heart rhythm has not shown clear benefits in large trials.

Catheter ablation for atrial fibrillation has demonstrated efficacy rates between 50% and 92% in maintaining sinus rhythm, leading to improvements in heart function, quality of life, and overall functional class.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Catheter ablation of atrial fibrillation in heart failure. Kirubakaran, S., O'Neill, MD.[2013]

Median nerve stimulation (MNS) in dogs significantly suppresses atrial electrical remodelling and reduces vulnerability to atrial fibrillation (AF), as shown by improved atrial effective refractory period (AERP) and decreased AF inducibility after rapid atrial pacing.

The beneficial effects of MNS are linked to reduced levels of inflammatory cytokines (TNF-a and IL-6) in the atrium, suggesting that MNS may work through the cholinergic anti-inflammatory pathway.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Median nerve stimulation prevents atrial electrical remodelling and inflammation in a canine model with rapid atrial pacing. Zhao, Q., Zhang, S., Zhao, H., et al.[2019]

Citations

1. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(25)01575-9/pdf

PO-05-170 NON-INVASIVE STIMULATION OF THE ... Median nerve stimulation. (MNS) is a non-invasive low-level electrical stimulation therapy which, in early studies, favorably affects atrial electrophysiology.

2. withpower.com withpower.com/trial/cardiacare-device-for-atrial-fibrillation-750fd

CardiaCare Device for Atrial Fibrillation · Info for Participants What data supports the effectiveness of the CardiaCare Device for Atrial Fibrillation treatment? The research highlights various non-drug treatments for atrial ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10911637/

Non-invasive Neuromodulation of Arrhythmias - PMC This review provides an evidence-based overview of the currently studied technologies capable of non-invasively modulating CANS for the suppression of atrial ...

4. cureus.com cureus.com/articles/361702-efficacy-of-transcutaneous-vagus-nerve-stimulation-to-suppress-paroxysmal-atrial-fibrillation-a-systematic-review

Efficacy of Transcutaneous Vagus Nerve Stimulation to ... Outcomes assessed across studies included suppression of arrhythmia episodes, changes in heart rate variability, levels of inflammatory markers, ...

5. ahajournals.org ahajournals.org/doi/10.1161/CIRCEP.119.007711

Electrical Stimulation of the Greater Auricular Nerve to ... No long-term outcomes regarding atrial fibrillation were assessed in this trial. The device under study is not approved to mitigate POAF in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12312889/

Safety of median nerve electrical stimulation in disorders of ... The results of the meta-analysis showed that MNS may not increase the incidence of complications and adverse events such as seizures, increased ...

7. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(25)01573-5/pdf

PO-05-168 ACUTE AND LONG TERM SAFETY AND ... Median nerve stimulation. (MNS) is a non-invasive low-level electrical stimulation therapy which, in early studies, favorably affects atrial electrophysiology.

8. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0324046

Safety of median nerve electrical stimulation in disorders of ... We found that MNS may not increase the incidence of complications and adverse events such as seizures, increased sympathetic activity, arrhythmia, nausea and ...

9. innovationsincrm.com innovationsincrm.com/cardiac-rhythm-management/articles-2024/february/2189-non-invasive-neuromodulation-of-arrhythmias

Non-invasive Neuromodulation of Arrhythmias While the initial data reported are promising, further studies examining clinical outcomes in patients with both atrial arrhythmia and VA are required before LL ...