A Phase 3 interventional study of Low-Level Tragus Stimulation and Heart Rate Variability- Biofeedback in Premature Ventricular Contraction, sponsored by Hunter Holmes Mcguire Veteran Affairs Medical Center. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-26.
Sponsored by Hunter Holmes Mcguire Veteran Affairs Medical Center · Phase 3, Interventional, and Treatment
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.
102 studies on the registry are indexed under Ventricular Premature Complexes; 32 are open to participants now.
Browse Ventricular Premature Complexes studies →Hunter Holmes Mcguire Veteran Affairs Medical Center is the lead sponsor of 31 studies on the registry; 1 is open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 2 (29%) have results posted.
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Exclusion Criteria:
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The Low-Level Tragus Stimulation will be done with TENS.
Device: Low-Level Tragus Stimulation
Heart Rate Variability-Biofeedback will be done with a phone application. Practice sessions are at least 10-15 minutes twice a daily.
Behavioral: Heart Rate Variability- Biofeedback
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.
Other: Conventional Medical Therapy
Low-Level Tragus Stimulation via TENS unit will be monitored with a Holter.
Also known as: TENS
Heart Rate Variability- Biofeedback will be monitored with a Holter.
Also known as: Breathing Exercises / Inner Balance
Conventional Medical Therapy by Beta Blockers will be added to subjects usual care by their doctor if they are not already taking this medication.
Also known as: Usual care medication
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.
Time frame: perspective 12-week study (each arm lasting two weeks with a one week washout between each arm)
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.
Time frame: perspective 12-week study (each arm lasting two weeks with a one-week washout between each arm)
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
This study is withdrawn, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Ventricular Premature Complexes →
Hunter Holmes Mcguire Veteran Affairs Medical Center