Premature Ventricular Contraction(NoVa-PVC)NCT05341544
Non-invasive Vagal Stimulation for Frequent Premature Ventricular Complexes
A study testing Parasym device in people with Premature Ventricular Contraction, run by Northwell Health at 2 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Premature Ventricular Contraction
- What is being tested?
- Parasym device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Aug 2022to 6 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 12Show fewer
- 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)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwell Health
New York, New York, 10075
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: Non-invasive Vagal Stimulation for Frequent Premature Ventricular Complexes (NoVa-PVC)
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.
- Conditions
- Premature Ventricular Contraction
- Being tested
- Parasym device, Sham device
- Medical subject headings
- Ventricular Premature Complexes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parasym deviceDevice
The study will utilize the Parasym device (Parasym Health, London, United Kingdom) paired with compatible electrodes to administer the transcutaneous LLTS.
Sham deviceDevice
Sham device
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Patients will receive 1 hour of active low level tragus stimulation daily for 10 days. Receives: Device: Parasym device |
| Sham | Sham comparator | Patients will receive 1 hour of sham low level tragus stimulation daily for 10 days. Receives: Device: Sham device |
What is being measured
The primary outcome is the main question the study is designed to answer.
PVC Burden
Daily PVC Count by event monitor
Measured: 28 days
Secondary outcomes (3)
Quality of life survey
SF 36 QOL Score
Measured: 28 days
Heart Rate Variability
Daily HRV
Measured: 28 days
PVC Morphology
Fluctuation in PVC Morphology by event monitor
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start22 Aug 2022
- Primary completion6 Apr 2026
- Study completion6 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premature Ventricular ContractionStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Patients will be allocated to either LLTS first and then sham-stimulation, or sham-stimulation first and then LLTS.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oklahoma
- Responsible party
- Principal investigator, Stavros E Mountantonakis, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05341544
- Sponsor's protocol ID
- 22-0076
- Acronym
- (NoVa-PVC)
- Status last verified
- Apr 2026
- First submitted
- 18 Apr 2022
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Vagal Stimulation for Frequent Premature Ventricular Complexes (NoVa-PVC)
- ClinicalTrials.gov ID
- NCT05341544
- Acronym / sponsor ID
- (NoVa-PVC) / 22-0076
- Conditions
- Premature Ventricular Contraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- University of Oklahoma
- Study start
- 22 Aug 2022 (actual)
- Primary completion
- 6 Apr 2026 (actual)
- Study completion
- 6 Apr 2026 (actual)
- First posted
- 22 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be allocated to either LLTS first and then sham-stimulation, or sham-stimulation first and then LLTS.
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Device: Parasym devicePatients will receive 1 hour of active low level tragus stimulation daily for 10 days. |
| Sham | Sham comparator | Device: Sham devicePatients will receive 1 hour of sham low level tragus stimulation daily for 10 days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parasym deviceThe study will utilize the Parasym device (Parasym Health, London, United Kingdom) paired with compatible electrodes to administer the transcutaneous LLTS. | Device | Active |
| Sham deviceSham device | Device | Sham |
Primary outcome
PVC Burden
Time frame: 28 days
Daily PVC Count by event monitor
3 secondary outcomes
Quality of life survey
Time frame: 28 days
Heart Rate Variability
Time frame: 28 days
PVC Morphology
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Derived from this study: PubMed 40392172Zafeiropoulos 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parasym device in people with Premature Ventricular Contraction, run by Northwell Health at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PVC Burden (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05341544, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.