Non-invasive Vagal Stimulation for Premature Ventricular Contractions

((NoVa-PVC) Trial)

Recruiting at 1 trial location

Overseen By Kristie Coleman, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwell Health

Disqualifiers: Heart failure, Valve disease, Pregnancy, Thyroid issues, others

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

Compensation: Varies

Number of Visits: 1

Duration: 20 days

60 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should be intolerant to or unwilling to take certain heart medications, or that these medications have been ineffective for them.

What data supports the effectiveness of the treatment for premature ventricular contractions?

Research shows that low-level tragus stimulation (LLTS), a form of non-invasive vagus nerve stimulation, has shown promising results in improving heart function and reducing arrhythmias in various cardiovascular conditions. It has been effective in conditions like atrial fibrillation and heart failure, suggesting potential benefits for managing premature ventricular contractions as well. ^{1 2 3 4 5}

Is non-invasive vagal stimulation safe for humans?

Non-invasive vagal stimulation, like low-level tragus stimulation, is generally considered safe and does not require surgery, making it more accessible and tolerable compared to surgically implanted devices. It has been used in studies for various conditions, showing promising results without significant safety concerns. ^{1 2 3 5 6}

How does the treatment for premature ventricular contractions using Low-level Tragus Stimulation differ from other treatments?

Low-level Tragus Stimulation (LLTS) is unique because it is a non-invasive treatment that uses electrical stimulation on the tragus (a part of the ear) to influence the vagus nerve, which can help balance the nervous system and potentially reduce heart rhythm issues. Unlike other treatments that might involve medication or surgery, LLTS is simple, portable, and does not require any surgical procedures. ^{1 2 3 5 7}

What is the purpose of this trial?

This trial tests if gentle ear stimulation can help patients with frequent irregular heartbeats by sending signals to the brain to control these abnormal rhythms.

Eligibility Criteria

This trial is for adults aged 18-80 with frequent premature ventricular complexes (PVCs) who can't or don't want to use certain heart medications. It's not for those with severe heart failure, valve disease, pregnant/nursing women, people with specific cardiac devices or metallic/electronic implants, thyroid issues, renal dialysis patients, certain types of heart block or autonomic dysfunction.

Inclusion Criteria

I have frequent or noticeable skipped heartbeats.

Beta blockers and calcium channel blockers don't work for me or I choose not to take them.

Exclusion Criteria

I have severe heart failure or serious heart valve problems.

I have had surgery on the nerves of my cervix.

I have experienced long episodes of rapid heartbeats.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Monitoring

Participants receive a cardiac event monitor for baseline data collection

28 days

1 visit (in-person) for device setup

Treatment

Participants receive either LLTS or sham-stimulation for 10 days, followed by a crossover to the alternate treatment for another 10 days

20 days

Daily sessions (self-administered)

Wash-out

An 8-day wash-out period between the two treatment phases

8 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

28 days

Treatment Details

Interventions

• Low-level Tragus Stimulation
• Parasym Device
• Sham Device

Trial Overview The study tests a non-invasive device called Parasym against a sham (fake) device to see if it helps reduce PVCs by stimulating the ear's tragus. Participants are randomly chosen to receive either the real treatment or a placebo in this controlled trial.

Participant Groups

Group I: Active Experimental Treatment 1 Intervention

Patients will receive 1 hour of active low level tragus stimulation daily for 10 days.

Group II: Sham Placebo Group 1 Intervention

Patients will receive 1 hour of sham low level tragus stimulation daily for 10 days.

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials

481

Recruited

470,000+

University of Oklahoma

Collaborator

Trials

484

Recruited

95,900+

Findings from Research

Low-level tragus stimulation (LLTS) is a promising non-invasive treatment that has shown potential benefits in managing various cardiovascular conditions, including atrial fibrillation (AF) and heart failure with preserved ejection fraction (HFpEF).

Preliminary clinical studies suggest that LLTS may improve heart function and reduce arrhythmias by positively influencing the balance between the sympathetic and parasympathetic nervous systems, although further research and larger trials are needed to confirm these effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-invasive Low-level Tragus Stimulation in Cardiovascular Diseases. Jiang, Y., Po, SS., Amil, F., et al.[2020]

In a study involving 24 patients with diastolic dysfunction, low-level transcutaneous vagus nerve stimulation (LLTS) significantly improved left ventricular function, as indicated by a 1.8% increase in global longitudinal strain compared to sham stimulation.

LLTS also positively affected heart rate variability, suggesting it enhances autonomic tone, which may contribute to better cardiac mechanics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autonomic Neuromodulation Acutely Ameliorates Left Ventricular Strain in Humans. Tran, N., Asad, Z., Elkholey, K., et al.[2020]

In a study involving 26 patients with ischemic cardiomyopathy and heart failure, acute low-level tragus stimulation (LLTS) was found to significantly increase the T-wave alternans (TWA) burden during sinus rhythm, indicating a potential risk for ventricular tachy-arrhythmias.

The study demonstrated that the increase in TWA burden was heart-rate dependent, particularly during right atrial pacing at 100 bpm, suggesting that LLTS may not have the desired anti-arrhythmic effects in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microvolt T-Wave Alternans Is Modulated by Acute Low-Level Tragus Stimulation in Patients With Ischemic Cardiomyopathy and Heart Failure. Kulkarni, K., Stavrakis, S., Elkholey, K., et al.[2021]

In a study involving 10 patients undergoing coronary artery bypass grafting, low-level vagus nerve stimulation through the tragus (tLLVNS) significantly increased unipolar potential voltage, indicating enhanced atrial electrophysiological properties.

Some patients experienced additional benefits during tLLVNS, such as reduced total activation time and changes in sinoatrial node exit sites, suggesting potential antiarrhythmic effects that could help in preventing atrial fibrillation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insights Into the Effects of Low-Level Vagus Nerve Stimulation on Atrial Electrophysiology: Towards Patient-Tailored Cardiac Neuromodulation. Kharbanda, RK., Ramdat Misier, NL., van Schie, MS., et al.[2023]

Transcutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive and cost-effective method for modulating the vagus nerve, making it a promising alternative to traditional surgical vagus nerve stimulation.

taVNS allows for easy and safe administration, with considerations for proper electrode placement and individual dosing based on perception thresholds, which enhances its potential for treating various central and peripheral diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laboratory Administration of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS): Technique, Targeting, and Considerations. Badran, BW., Yu, AB., Adair, D., et al.[2020]

Vagus nerve stimulation (VNS) is effective for treating refractory epilepsy and depression, but traditional methods involve surgical implantation, which carries risks such as infection and bradycardia.

New non-invasive VNS systems eliminate the need for surgery, improving safety and tolerability, and allowing patients to administer stimulation on demand, potentially expanding its use in various medical conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgically implanted and non-invasive vagus nerve stimulation: a review of efficacy, safety and tolerability. Ben-Menachem, E., Revesz, D., Simon, BJ., et al.[2022]

Chronic low-level tragus stimulation (LLTS) significantly reduced the burden of paroxysmal atrial fibrillation (AF) by 85% over 6 months compared to a sham control, indicating its potential as an effective treatment option.

The active LLTS group also showed a significant 23% reduction in tumor necrosis factor-alpha levels and improved heart rate variability, with no reported side effects, suggesting both safety and efficacy in managing AF.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TREAT AF (Transcutaneous Electrical Vagus Nerve Stimulation to Suppress Atrial Fibrillation): A Randomized Clinical Trial. Stavrakis, S., Stoner, JA., Humphrey, MB., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Non-invasive Low-level Tragus Stimulation in Cardiovascular Diseases. [2020]

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

Autonomic Neuromodulation Acutely Ameliorates Left Ventricular Strain in Humans. [2020]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Microvolt T-Wave Alternans Is Modulated by Acute Low-Level Tragus Stimulation in Patients With Ischemic Cardiomyopathy and Heart Failure. [2021]

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

Insights Into the Effects of Low-Level Vagus Nerve Stimulation on Atrial Electrophysiology: Towards Patient-Tailored Cardiac Neuromodulation. [2023]

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

Laboratory Administration of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS): Technique, Targeting, and Considerations. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Surgically implanted and non-invasive vagus nerve stimulation: a review of efficacy, safety and tolerability. [2022]

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

TREAT AF (Transcutaneous Electrical Vagus Nerve Stimulation to Suppress Atrial Fibrillation): A Randomized Clinical Trial. [2021]