Premature Ventricular ContractionPhase 3NCT06110364
Vagal Nerve Stimulation as an Alternative Therapy for Premature Ventricular Contractions
A Phase 3 study testing Low-Level Tragus Stimulation, Heart Rate Variability- Biofeedback and Conventional Medical Therapy in people with Premature Ventricular Contraction, run by Hunter Holmes Mcguire Veteran Affairs Medical Center at 1 site in United States.
Trial summary
Prospective randomized control pilot study Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Premature Ventricular Contraction
- What is being tested?
- Low-Level Tragus Stimulation, Heart Rate Variability- Biofeedback and Conventional Medical Therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jul 2023to 13 Aug 2024
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Normal Left Ventricular systolic function
- Frequent PVCs
Who cannot join
- Current use of any (I and/or III) antiarrhythmic medication
- Contraindication to use beta blockers and non-dihydropyridine calcium channel blockers
- Complete Atrioventricular block and pacemaker dependent
- Ongoing uncontrolled hypertension with systolic Blood Pressure> 180
- Family history of dilated Cardiomyopathy in a first degree relative
- Alcohol use disorder or illicit drug use
Show all 9Show fewer
- Actively being treated Atrial fibrillation/ Flutter with Rapid Ventricular Response
- Moderate to severe valve disorders
- Patient with shortwave/microwave therapy equipment
Trial locations and contacts
1 site in 1 country.
United States1 site
Richmond VA Medical Center
Richmond, Virginia, 23249
About this study
Prospective randomized control pilot study
Read the detailed description
The primary aims of this investigator initiated study is :
Aim 1: to assess the ability of non-invasive vagal nerve stimulation to suppress Premature Ventricular Contractions and Aim 2: to compare the efficacy of Lower-level Tragus stimulation and Heart rate variability- Biofeedback in suppression of Premature Ventricular Contractions.
- Conditions
- Premature Ventricular Contraction
- Being tested
- Low-Level Tragus Stimulation, Heart Rate Variability- Biofeedback, Conventional Medical Therapy
- Keywords
- NIVNS Non-invasive vagal nerve stimulation, LLTS- Low-level tragus stimulation, HRV-BF - Heart rate variability biofeedback
- 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.
Low-Level Tragus StimulationDevice
Also called TENS
Low-Level Tragus Stimulation via TENS unit will be monitored with a Holter.
Heart Rate Variability- BiofeedbackBehavioural
Also called Breathing Exercises / Inner Balance
Heart Rate Variability- Biofeedback will be monitored with a Holter.
Conventional Medical TherapyOther
Also called Usual care medication
Conventional Medical Therapy by Beta Blockers will be added to subjects usual care by their doctor if they are not already taking this medication.
| Study group | Role | What they receive |
|---|---|---|
| Low-Level Tragus Stimulation | Experimental | The Low-Level Tragus Stimulation will be done with TENS. Receives: Device: Low-Level Tragus Stimulation |
| Heart Rate Variability- Biofeedback | Experimental | Heart Rate Variability-Biofeedback will be done with a phone application. Practice sessions are at least 10-15 minutes twice a daily. Receives: Behavioral: Heart Rate Variability- Biofeedback |
| Conventional Medical Therapy | Active comparator | Subjects without beta blockers will be initiated on a usual/standard care medication of beta blockers to determine the efficacy of this standard medication therapy for Premature Ventricular Contraction suppression. Receives: Other: Conventional Medical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the ability of non-invasive vagal nerve stimulation to suppress Premature Ventricular Contractions.
Compare the effects of Premature Ventricular Contractions suppression between standard medical therapy and non-invasive vagal nerve stimulation.
Measured: perspective 12-week study (each arm lasting two weeks with a one week washout between each arm)
Secondary outcomes (1)
Compare the efficacy of non-invasive vagal nerve stimulation via lower-level vagal stimulation and heart rate variability in suppression of Premature Ventricular Contractions.
It is speculated that Heart Rate Variability-Biofeedback is as effective as Lower Level Tragus Stimulation to achieve successful Premature Ventricular Contraction suppression.
Measured: perspective 12-week study (each arm lasting two weeks with a one-week washout between each arm)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start19 Jul 2023
- Primary completion30 Jul 2024
- Study completion13 Aug 2024
Why it stopped: Study Closed due to funding; no subjects enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Ventricular ContractionStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Patients will be randomized to Premature ventricular contraction suppression strategies: 1) Lower level tragus stimulation 2) Heart rate variability biofeedback and 3) conventional medical therapy (usual care)
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hunter Holmes Mcguire Veteran Affairs Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Virginia Commonwealth University
- Responsible party
- Principal investigator, Jose Huizar, Hunter Holmes Mcguire Veteran Affairs Medical Center
- Investigators
- Jose Huizar, M.D., Principal investigator, Hunter Holmes McGuire Veterans Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06110364
- Sponsor's protocol ID
- 1724039
- Status last verified
- Oct 2024
- First submitted
- 26 Oct 2023
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vagal Nerve Stimulation as an Alternative Therapy for Premature Ventricular Contractions
- ClinicalTrials.gov ID
- NCT06110364
- Acronym / sponsor ID
- 1724039
- Conditions
- Premature Ventricular Contraction
- Keywords
- NIVNS Non-invasive vagal nerve stimulation, LLTS- Low-level tragus stimulation, HRV-BF - Heart rate variability biofeedback
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study Closed due to funding; no subjects enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hunter Holmes Mcguire Veteran Affairs Medical CenterUS federal agency
- Collaborators
- Virginia Commonwealth University
- Study start
- 19 Jul 2023 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 13 Aug 2024 (actual)
- First posted
- 31 Oct 2023 (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.
Prospective randomized control pilot study
Detailed description
The primary aims of this investigator initiated study is :
Aim 1: to assess the ability of non-invasive vagal nerve stimulation to suppress Premature Ventricular Contractions and Aim 2: to compare the efficacy of Lower-level Tragus stimulation and Heart rate variability- Biofeedback in suppression of Premature Ventricular Contractions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Patients will be randomized to Premature ventricular contraction suppression strategies: 1) Lower level tragus stimulation 2) Heart rate variability biofeedback and 3) conventional medical therapy (usual care)
| Arm | Type | Receives |
|---|---|---|
| Low-Level Tragus Stimulation | Experimental | Device: Low-Level Tragus StimulationThe Low-Level Tragus Stimulation will be done with TENS. |
| Heart Rate Variability- Biofeedback | Experimental | Behavioral: Heart Rate Variability- BiofeedbackHeart Rate Variability-Biofeedback will be done with a phone application. Practice sessions are at least 10-15 minutes twice a daily. |
| Conventional Medical Therapy | Active comparator | Other: Conventional Medical TherapySubjects without beta blockers will be initiated on a usual/standard care medication of beta blockers to determine the efficacy of this standard medication therapy for Premature Ventricular Contraction suppression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Normal Left Ventricular systolic function
- Frequent PVCs
Key exclusion criteria (9 listed)
- Current use of any (I and/or III) antiarrhythmic medication
- Contraindication to use beta blockers and non-dihydropyridine calcium channel blockers
- Complete Atrioventricular block and pacemaker dependent
- Ongoing uncontrolled hypertension with systolic Blood Pressure> 180
- Family history of dilated Cardiomyopathy in a first degree relative
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 |
|---|---|---|
| Low-Level Tragus StimulationAlso: TENSLow-Level Tragus Stimulation via TENS unit will be monitored with a Holter. | Device | Low-Level Tragus Stimulation |
| Heart Rate Variability- BiofeedbackAlso: Breathing Exercises / Inner BalanceHeart Rate Variability- Biofeedback will be monitored with a Holter. | Behavioural | Heart Rate Variability- Biofeedback |
| Conventional Medical TherapyAlso: Usual care medicationConventional Medical Therapy by Beta Blockers will be added to subjects usual care by their doctor if they are not already taking this medication. | Other | Conventional Medical Therapy |
Primary outcome
Assess the ability of non-invasive vagal nerve stimulation to suppress Premature Ventricular Contractions.
Time frame: perspective 12-week study (each arm lasting two weeks with a one week washout between each arm)
Compare the effects of Premature Ventricular Contractions suppression between standard medical therapy and non-invasive vagal nerve stimulation.
1 secondary outcome
Compare the efficacy of non-invasive vagal nerve stimulation via lower-level vagal stimulation and heart rate variability in suppression of Premature Ventricular Contractions.
Time frame: perspective 12-week study (each arm lasting two weeks with a one-week washout between each arm)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- Premature ventricular contractions activate vagal afferents and alter autonomic tone: implications for premature ventricular contraction-induced cardiomyopathyLink provided by the sponsor.
- Relationship between burden of premature ventricular complexes and left ventricular functionLink provided by the sponsor.
- Clinical and translational insights on premature ventricular contractions and PVC-induced cardiomyopathyLink provided by the sponsor.
- Evaluation and management of premature ventricular complexesLink provided by the sponsor.
- Stellate ganglion blockade and bilateral cardiac sympathetic denervation in patients with life-threatening ventricular arrhythmiasLink provided by the sponsor.
- Cardiac Sympathetic Denervation for Refractory Ventricular ArrhythmiasLink provided by the sponsor.
- 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.
Jose Huizar, M.D. principal investigator
Hunter Holmes McGuire Veterans Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Low-Level Tragus Stimulation, Heart Rate Variability- Biofeedback and Conventional Medical Therapy in people with Premature Ventricular Contraction, run by Hunter Holmes Mcguire Veteran Affairs Medical Center at 1 site 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 2 inclusion and 9 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: withdrawn, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Assess the ability of non-invasive vagal nerve stimulation to suppress Premature Ventricular Contractions. (time frame: perspective 12-week study (each arm lasting two weeks with a one week washout between each arm)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2024.