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Study Closed due to funding; no subjects enrolled
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| Name | Class |
|---|---|
| Virginia Commonwealth University | OTHER |
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Prospective randomized control pilot study
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-Level Tragus Stimulation | Experimental | The Low-Level Tragus Stimulation will be done with TENS. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-Level Tragus Stimulation | Device | Low-Level Tragus Stimulation via TENS unit will be monitored with a Holter. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | perspective 12-week study (each arm lasting two weeks with a one week washout between each arm) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | perspective 12-week study (each arm lasting two weeks with a one-week washout between each arm) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jose Huizar, M.D. | Hunter Holmes McGuire Veterans Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Richmond VA Medical Center | Richmond | Virginia | 23249 | United States |
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| Label | URL |
|---|---|
| Premature ventricular contractions activate vagal afferents and alter autonomic tone: implications for premature ventricular contraction-induced cardiomyopathy | View source |
| Relationship between burden of premature ventricular complexes and left ventricular function | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 12, 2023 | Oct 3, 2024 |
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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)
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| Heart Rate Variability- Biofeedback | Behavioral | Heart Rate Variability- Biofeedback will be monitored with a Holter. |
|
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| Conventional Medical Therapy | Other | Conventional Medical Therapy by Beta Blockers will be added to subjects usual care by their doctor if they are not already taking this medication. |
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| Clinical and translational insights on premature ventricular contractions and PVC-induced cardiomyopathy |
| View source |
| Evaluation and management of premature ventricular complexes | View source |
| Stellate ganglion blockade and bilateral cardiac sympathetic denervation in patients with life-threatening ventricular arrhythmias | View source |
| Cardiac Sympathetic Denervation for Refractory Ventricular Arrhythmias | View source |
| TREAT AF (Transcutaneous Electrical Vagus Nerve Stimulation to Suppress Atrial Fibrillation): A Randomized Clinical Trial | View source |
| Heart rate variability biofeedback based on slow-paced breathing with immersive virtual reality nature scenery. | View source |
| Non-invasive low-level tragus stimulation in cardiovascular diseases | View source |
| Critical Review of Transcutaneous Vagus Nerve Stimulation: Challenges for Translation to Clinical Practice | View source |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D018879 | Ventricular Premature Complexes |
| ID | Term |
|---|---|
| D005117 | Cardiac Complexes, Premature |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| D001945 | Breathing Exercises |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D026241 | Exercise Movement Techniques |
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