What side effects are associated with this type of intervention?

Common treatments for Premature Ventricular Contractions (PVCs) include beta-blockers, calcium channel blockers, and antiarrhythmic drugs. Beta-blockers can cause fatigue, dizziness, and bradycardia. Calcium channel blockers may lead to constipation, dizziness, and swelling in the lower extremities. Antiarrhythmic drugs can have more severe side effects, such as proarrhythmia, liver toxicity, and lung damage. Treatments similar to Low-Level Tragus Stimulation (LLTS), which modulate autonomic nervous system activity, generally have mild side effects. These can include sensations of warmth, numbness, redness, itching, tingling, and muscle spasms. Serious adverse events are rare.

What prior FDA approvals exist?

There is no specific mention of FDA-approved treatments for Premature Ventricular Contractions (PVCs) that are similar to Low-Level Tragus Stimulation (LLTS) in the provided context. Generally, treatments for PVCs include medications such as beta-blockers, calcium channel blockers, and antiarrhythmic drugs. Neuromodulation techniques like LLTS, which aim to modulate autonomic nervous system activity, are still under investigation and have not been highlighted as FDA-approved treatments for PVCs.

What other types of research exist?

Promising novel alternatives to Low-Level Tragus Stimulation (LLTS) for treating Premature Ventricular Contractions (PVCs) include: 1) Vagus Nerve Stimulation (VNS), which has shown efficacy in modulating autonomic nervous system activity; 2) Closed-Loop Stimulation (CLS) cardiac pacing, which has been effective in reducing recurrent vasovagal syncope and may have potential for PVCs; and 3) Deep Brain Stimulation (DBS), which is being explored for various cardiac arrhythmias. Patients should discuss these options with their healthcare provider to determine the most appropriate treatment.

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Vagal Stimulation

Non-invasive Vagal Stimulation for Premature Ventricular Contractions ((NoVa-PVC) Trial)

Q: What is the mechanism of action of this treatment?

The most common treatments for Premature Ventricular Contractions (PVCs) often involve modulation of the autonomic nervous system to reduce the frequency and severity of PVCs. Low-Level Tragus Stimulation (LLTS) works by stimulating the vagus nerve, which can help balance the autonomic nervous system and reduce sympathetic activity that may trigger PVCs. This is important for PVC patients as it offers a non-invasive method to manage symptoms and potentially reduce the need for more aggressive treatments like antiarrhythmic drugs or invasive procedures. Other common treatments include beta-blockers, which reduce sympathetic nervous system activity, and calcium channel blockers, which help to stabilize the heart's electrical activity. These treatments are crucial as they help to manage symptoms, improve quality of life, and reduce the risk of more serious arrhythmias.

N/A

Recruiting

Research Sponsored by Northwell Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Symptomatic PVCs or asymptomatic PVCs with a burden > 5%

Intolerant to or unwilling to take beta blockers and nondihydropyridine calcium channel blockers or beta blockers and nondihydropyridine calcium channel blockers have proved ineffective

Must not have

Severe heart failure (New York Heart Association Class III, or IV) or valve disease

Patients who have had prior cervical vagotomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 28 days

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort at the stimulation site on the ear and possible skin irritation. Since it's non-invasive and doesn't involve drugs, fewer systemic side effects are expected compared to medication-based treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have frequent or noticeable skipped heartbeats.

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

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I am between 18 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have severe heart failure or serious heart valve problems.

Select...

I have had surgery on the nerves of my cervix.

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I have experienced long episodes of rapid heartbeats.

Select...

My skin on the tragus is broken or cracked.

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I have a history of heart disease or severe artery narrowing.

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I have heart disease or scar tissue in my heart.

Select...

I have thyroid problems and am on kidney dialysis.

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I have low blood pressure due to a nerve system issue.

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My heart's pumping ability is reduced (LVEF < 40%).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~28 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

PVC Burden

Secondary study objectives

Heart Rate Variability

PVC Morphology

Quality of life survey

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ActiveExperimental Treatment1 Intervention

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

Group II: ShamPlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Parasym device

2016

N/A

~60

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Premature Ventricular Contractions (PVCs) often involve modulation of the autonomic nervous system to reduce the frequency and severity of PVCs. Low-Level Tragus Stimulation (LLTS) works by stimulating the vagus nerve, which can help balance the autonomic nervous system and reduce sympathetic activity that may trigger PVCs. This is important for PVC patients as it offers a non-invasive method to manage symptoms and potentially reduce the need for more aggressive treatments like antiarrhythmic drugs or invasive procedures. Other common treatments include beta-blockers, which reduce sympathetic nervous system activity, and calcium channel blockers, which help to stabilize the heart's electrical activity. These treatments are crucial as they help to manage symptoms, improve quality of life, and reduce the risk of more serious arrhythmias.

Surgery for Wolff-Parkinson-White syndrome interrupts efferent vagal innervation to the left ventricle and to the atrioventricular node in the canine heart.