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CompletedNCT05341544(NoVa-PVC)Updated Apr 7, 2026

Non-invasive Vagal Stimulation for Frequent Premature Ventricular Complexes

An interventional study of Parasym device and Sham device in Premature Ventricular Contraction, sponsored by Northwell Health. Completed at 2 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-04-07.

Sponsored by Northwell Health · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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)

Read the detailed description

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.

02

Conditions studied

  • Premature Ventricular Contraction
03

In context

Ventricular Premature Complexes

102 studies on the registry are indexed under Ventricular Premature Complexes; 32 are open to participants now.

This study's enrollment of 60 is below the median of 84 across 58 interventional studies indexed under Ventricular Premature Complexes.

Browse Ventricular Premature Complexes studies →

Lead sponsor

Northwell Health is the lead sponsor of 475 studies on the registry; 107 are open to participants now.

Of its 45 completed or terminated interventional studies of FDA-regulated products, 23 (51%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Ischemic cardiomyopathy with \< 40%
  • Severe heart failure ( 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)
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Active

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

    Device: Parasym device

  • Sham comparator
    Sham

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

    Device: Sham device

Interventions

  • DeviceParasym device

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

  • DeviceSham device

    Sham device

06

What researchers measure

Primary outcomes

  1. PVC Burden

    Daily PVC Count by event monitor

    Time frame: 28 days

Secondary outcomes

  1. Quality of life survey

    SF 36 QOL Score

    Time frame: 28 days

  2. Heart Rate Variability

    Daily HRV

    Time frame: 28 days

  3. PVC Morphology

    Fluctuation in PVC Morphology by event monitor

    Time frame: 28 days

07

Study locations

2 sites
  • Northwell Health
    New York, New York 10075, United States
  • University of Oklahoma Health Sciences Center
    Oklahoma City, Oklahoma 73104, United States
08

References and documents

Publications

  • Zafeiropoulos S, Coleman K, Kogan J, Varrias D, Leavitt J, Bekiaridou A, Zanos T, Zanos S, Stavrakis S, Mountantonakis S. Transcutaneous Electrical Vagus Nerve Stimulation to Suppress Premature Ventricular Contractions: A Crossover, Randomized Clinical Trial (NoVa-PVC). JACC Clin Electrophysiol. 2025 Aug;11(8):1699-1707. doi: 10.1016/j.jacep.2025.04.011. Epub 2025 Apr 24. PubMed 40392172 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2022 to primary completion in Apr 2026, 43 months.

Of 32 interventional studies with no phase under Ventricular Premature Complexes, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 52. This study's 43 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 18, 2022
First posted
Apr 22, 2022
StartActual
Aug 22, 2022
Primary completionActual
Apr 6, 2026
CompletionActual
Apr 6, 2026
Last update
Apr 7, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05341544
Lead sponsor
Northwell Health
Responsible party
Stavros E Mountantonakis (Director, Cardiac Electrophysiology, Lenox Hill Hospital, Northwell Health) — Principal investigator
First posted
Apr 22, 2022
Start date
Aug 22, 2022
Primary completion
Apr 6, 2026
Completion
Apr 6, 2026
Last update
Apr 7, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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