Atrial Fibrillation
Conditions
Interventions
Intervention Group:Low-level tragus stimulation
Control Group:Sham control
Sponsors
The First Affiliated Hospital of Nanjing Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18-80 years; 2. Symptomatic Afib refractory to >= 1 antiarrhythmic drugs (including belta-blockers and calcium-channel blockers); 3. Informed consent and voluntary participation.
Exclusion criteria
Exclusion criteria: 1. EF 15% when Afib burden was reduced by pharmacological agents or ablation); 2. EF continues to decrease in the past 4 months regardless of the etiology; 3. Unwilling to continue current pharmacological therapy during the study period (6 months); 4. Severe heart failure with NYHA Class >= III; 5. Afib attributed to underlying structural heart disease, known myocardial scar or myocarditis 6. Change the dosing of anti-arrhythmic drug, including belta-blockers and calcium channel blockers, within 2 months prior to enrollment; 7. Unsuccessful ablation within 3 months before recruitment; 8. Patients are on amiodarone; 9. Patients with known thyroid issues, or renal dialysis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Atrial Fibrillation Effect on Quality of Life, AFEQT;Mayo AF-Specific Symptom Inventory, MAFSI; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duke Activity Status Index, DASI;Atrial Fibrillation Severity Scale, AFSS;SF-36;European Five Dimensional Health Scale;Atrial fibrillation burden assessed by 10-day holter;Skin sympathetic nerve activity;Therapy compliance; | — |
Countries
China
Contacts
Public ContactGang Yang
The First Affiliated Hospital of Nanjing Medical University
Outcome results
None listed