Postoperative atrial fibrillation. Paroxysmal atrial fibrillation
Conditions
Interventions
Intervention 1: Intervention group: Exposure to the active status of ta-VNS set to burst pulses of 30 on, 30 s off, 20 Hz frequency, 200 microseconds PW, and at 80% or 0.5 mA current on the left tragu
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Adult subjects who are candidate for an elective CABG Age = 18 Sinus rhythm at baseline ECG
Exclusion criteria
Exclusion criteria: Patients with a documented history of AF and other supraventricular arrhythmia Hemodynamic instability that required inotropic agents Severe congestive heart failure (New York Heart Association class III or IV) Congenital heart disease Chronic use of amiodarone High-degree atrioventricular block that required temporary pacing Symptomatic sinus bradycardia or sinus node dysfunction at baseline without an implantable pacemaker Recent stroke within the past 6 months Recurrent vasovagal syncope Known channelopathy such as Brugada syndrome, long QT syndrome, or Catecholaminergic monomorphic ventricular tachycardia The presence of a pacemaker or an implanted cardioverter-defibrillator Pregnancy Facial or ear pain, or recent ear trauma Unable or unwilling to comply with protocol requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility of the intervention. Timepoint: At the end of the study. Method of measurement: The amount of time (in minutes) of device use per day and Number of completed session.;Feasibility of the measurements and assessments procedures. Timepoint: At the end of the study. Method of measurement: The number of completed assessments.;Acceptability of the intervention. Timepoint: At the end of the study. Method of measurement: TAQ questionnaire.;Safety of the study. Timepoint: After intervention on a daily basis. Method of measurement: Physical examination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of in-hospital POAF. Timepoint: Days 0 to 4 (or at discharge day, whichever is earlier). Method of measurement: 24-hour ECG holter monitoring.;Time to first POAF event. Timepoint: Patients will be seen on a daily basis from day 0 to day 4 and the timing of first POAF event will be recorded. Method of measurement: 24-hour ECG holter monitoring.;Duration of incident post-op atrial fibrillation. Timepoint: Daily assessment from day 0 to day 4 until the first POAF event occurred and recording the duration of that. Method of measurement: 24-hour ECG holter monitoring.;Heart rate during incident first POAF event. Timepoint: Daily assessment from day 0 to day 4 until the first POAF event occurred and recording the HR during that. Method of measurement: 24-hour ECG holter monitoring.;Changes in heart rate after intervention. Timepoint: before and after intervention on a daily basis. Method of measurement: ICU monitoring device.;Changes in blood pressure after intervention. Timepoint: before and after intervention on a daily basis. Method of measurement: ICU monitoring device.;Changes in hs-CRP level. Timepoint: Days 0, 2 and 4. Method of measurement: Laboratory assessment.;Changes in NT-Pro BNP level. Timepoint: Days 0, 2 and 4. Method of measurement: Laboratory assessment.;Changes in CBC parameters. Timepoint: Days 0, 2 and 4. Method of measurement: Laboratory assessment.;Days of hospitalization. Timepoint: At discharge day. Method of measurement: The number of hospitalization days. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDanesh Soltani
Tehran University of Medical Sciences
Outcome results
None listed