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

34 Participants Needed

Trial Summary

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 data supports the effectiveness of the CardiaCare Device for Atrial Fibrillation treatment?

The research highlights various non-drug treatments for atrial fibrillation, such as pacing and defibrillation, which have shown potential in managing the condition. Although not directly related to the CardiaCare Device, these studies suggest that non-invasive approaches can be effective in treating atrial fibrillation. ^{1 2 3 4 5}

How is the CardiaCare Device treatment for atrial fibrillation different from other treatments?

The CardiaCare Device uses non-invasive median nerve stimulation, which is unique because it reduces cardiac sympathetic drive and prevents atrial electrical remodeling, unlike traditional treatments that often involve medication or invasive procedures. ^{6 7 8 9 10}

What is the purpose of this trial?

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: 1. early (0-2 months) post-ablation arrhythmias that occur in the immediate post-ablation time period 2. 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.

Research Team

Vivek Reddy, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Mohit Turagam, MD

Principal Investigator

Icahn School of Medicine at MS

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Dynamic and dual-site atrial pacing in the prevention of atrial fibrillation: The STimolazione Atrial DInamica Multisito (STADIM) Study. [2008]

2. United States pubmed.ncbi.nlm.nih.gov

The future role of defibrillators in the management of atrial fibrillation. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Nonpharmacologic strategies for treating atrial fibrillation. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Nonpharmacologic therapies for atrial fibrillation. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Catheter ablation of atrial fibrillation in heart failure. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

Subcutaneous nerve stimulation for rate control in ambulatory dogs with persistent atrial fibrillation. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Chronic median nerve modulation reduces ventricular arrhythmia and improves ventricular function in a postmyocardial infarction rabbit model. [2018]

8. China pubmed.ncbi.nlm.nih.gov

[A wireless implantable stimulating and ECG monitoring system for animal models of chronic atrial fibrillation]. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Median nerve stimulation prevents atrial electrical remodelling and inflammation in a canine model with rapid atrial pacing. [2019]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Cardioneuroablation Using Epicardial Pulsed Field Ablation for the Treatment of Atrial Fibrillation. [2023]