Vagus nerve stimulation on atrial fibrillation

The effect of transcutaneous auricular vagus nerve stimulation in reducing the burden of Atrial tachycardia/Atrial Fibrillation: a pilot study on feasibility, acceptability and safety

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20130707013886N4

Enrollment

Registered

2024-10-19

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: Atrial fibrillation. Condition 2: Paroxysmal Tachycardia. Atrial fibrillation and flutter Paroxysmal tachycardia

Interventions

Intervention 1: Intervention group: Vagus nerve stimulation would be applied through left ear tragus region with pulses of 20 Hz frequency, 200 milliseconds pulse width, amplitude 0.5 mA below the pai

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: AT/AF for more than 3 months at least ten 5-30 seconds AT/AF episodes

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 pacemaker, hearing aids implants, any metal implants or implanted vagus stimulator

Design outcomes

Primary

Measure	Time frame
Burden of atrial fibrillation/ atrial tachycardia. Timepoint: AT/AF burden will be evaluated before and one month after the initiation of the study. Method of measurement: AT/AF burden will be determined using 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).	—

Measure

Time frame

Burden of atrial fibrillation/ atrial tachycardia. Timepoint: AT/AF burden will be evaluated before and one month after the initiation of the study. Method of measurement: AT/AF burden will be determined using 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.;HsCRP. 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