Non-invasive Vagal Stimulation for Frequent Premature Ventricular Complexes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-22

Study Completion Date

2025-12-22

Brief Summary

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A prospective sham-controlled randomized clinical trial to assess the effect of low-level tragus stimulation (LLTS) in patients with frequent premature ventricular complexes (PVCs)

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Detailed Description

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This is a two-center, prospective, cross-over, sham-controlled, double-blinded, randomized clinical trial. All the patients will receive a cardiac event monitor at baseline for 28 days, the patient will switch the ePatch after 14 days . Patients will be allocated to either LLTS first and then sham-stimulation, or sham-stimulation first and then LLTS. Each treatment period (sham-stimulation and LLTS) will last 10 days. The Parasym device will be used, and the patients will receive LLTS or sham-stimulation for 1 hour daily. The wash-out period between the two treatments will last 8 days. Patients will be continually monitored via event monitor for 28 days in duration.

Conditions

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Premature Ventricular Contraction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Patients will be allocated to either LLTS first and then sham-stimulation, or sham-stimulation first and then LLTS.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Active

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

Group Type EXPERIMENTAL

Parasym device

Intervention Type DEVICE

The study will utilize the Parasym device (Parasym Health, London, United Kingdom) paired with compatible electrodes to administer the transcutaneous LLTS.

Sham

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

Group Type SHAM_COMPARATOR

Sham device

Intervention Type DEVICE

Sham device

Interventions

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Parasym device

The study will utilize the Parasym device (Parasym Health, London, United Kingdom) paired with compatible electrodes to administer the transcutaneous LLTS.

Intervention Type DEVICE

Sham device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adults (\>18 years old) but \< 80 years of age
* 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

Exclusion Criteria

* Ischemic cardiomyopathy with LVEF \< 40%
* Severe heart failure (New York Heart Association Class III, or IV) or valve disease
* Sustained ventricular tachycardia
* Structural heart disease or myocardial scar
* Pregnancy or nursing
* Patients with known thyroid issues, on renal dialysis.
* Patients with prolonged first-degree block, high degree AV block (2nd or 3rd degree), bivascular block and documented sick sinus syndrome
* Hypotension due to autonomic dysfunction
* Patients with cardiac implantable electronic device (ICD or PPM) , hearing aid implants or any implanted metallic or electronic device
* Patients who have had prior cervical vagotomy
* Patients with skin on the tragus that is broken or cracked
* Patients with a history of baseline cardiac disease or atherosclerotic cardiovascular disease, including congestive heart failure (CHF), known severe coronary artery disease or recent myocardial infarction (within 5 years) and patients diagnosed with narrowing of the arteries (carotid atherosclerosis)

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No