Condition 1: Premature atrial complex. Condition 2: Premature ventricular complex. Atrial premature depolarization Ventricular premature depolarization
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: PAC/PVC burden of 10-15% non-responsive to pharmacologic treatment
Exclusion criteria
Exclusion criteria: History of cardiac ablation Left or right bundle branch block or known disease concerning cardiac conduction system Pregnancy or lactation History of cervical vagotomy Dermatological or structural deformity in the auricular or tragus region Severe congestive heart failure Severe coronary artery disease History of myocardial infarction within the last 5 years History of stroke Other known dysrhythmia Severe arterial stenosis Active medical implants including Pacemakers, Hearing aid implants, any metal implants or implanted vagus stimulator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Burden of PAC/PVC. Timepoint: PAC/PVC burden will be evaluated before and one month after the initiation of the study. Method of measurement: 24 hours ECG Holter monitoring.;Feasibility. Timepoint: at each session (12 sessions). Method of measurement: Number of completed session and the total use time.;Safety. Timepoint: at each session (12 sessions). Method of measurement: physical examination and history taking.;Acceptance. Timepoint: After the completion of the study. Method of measurement: Treatment Acceptance Questionnaire (TAQ). | — |
Secondary
| Measure | Time frame |
|---|---|
| Heart Rate Variability. Timepoint: Before and one month after the initiation of the study. Method of measurement: 24 Hours ECG Holter monitoring.;Hemodynamic. Timepoint: at each session (12 sessions). Method of measurement: Measuring blood pressure and heart rate.;IL-6. Timepoint: Before and one month after the initiation of the study. Method of measurement: ELISA.;TNF-a. Timepoint: Before and one month after the initiation of the study. Method of measurement: ELISA. | — |
Countries
Iran (Islamic Republic of)
Contacts
Tehran University of Medical Sciences