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Vagus nerve stimulation on premature cardiac contractions

Effect of auricular vagus nerve stimulation in frequent PAC/PVC: a pilot study on feasibility, acceptability and safety

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20130707013886N6
Enrollment
36
Registered
2024-11-03
Start date
2024-12-21
Completion date
Unknown
Last updated
2025-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: Premature atrial complex. Condition 2: Premature ventricular complex. Atrial premature depolarization Ventricular premature depolarization

Interventions

Intervention 1: Intervention group: Intervention group: Vagus nerve stimulation would be applied through left ear tragus region with pulses of 20 Hz frequency, 200 milliseconds pulse width, amplitude

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

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

MeasureTime 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

MeasureTime 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

Public ContactMuhammadhosein Moradi

Tehran University of Medical Sciences

dr.mhmoradi1997@gmail.com+98 21 8802 9256

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026