Table 1 Summary of 8 sections of eCRF and site questionnaire
Site Questionnaire | Enrollment | Demographics | Information on AF | Medical treatment Prior to enrollment | Diagnostic Procedures | Acute Treatment of AF | Discharge | Follow-up at 60 days |
|---|---|---|---|---|---|---|---|---|
Center characteristics (type, size, units) | Demographics (age, gender, ethnicity) | Anthropometrics (ht, wt, bp) | Current episode (symptoms, type, time of onset, triggers) | ATT, rate control, other (type, indication, dose) | Laboratory measures (Hg, K, sCr, PG, INR-T) | AA/Rate control (type, dose), | Basics (vital status, date, time, destination) | Contact information (mode, date) |
Specialties at site (clinics, physicians, number and availability, procedures available) | Admission information (date, time, site, reason) | Medical history (CVD, CHF, details thereof) | History of AF (date, frequency, nature, treatment) | ECG (rhythm, rate, PR & QT interval, QRS duration, LVH) | PCV & ECV (labs before, after, type, dose/joules & number of shocks route, worked?, time to SR, SR after) | Rhythm at discharge; LoS by unit | Basics (vital status, current rhyuthm) | |
Most frequent and most preferred approach to cardioversion | ECG information (date, time, results) | History of risk factors (family hx of disease, DM, smoking, htn, hyperlipidemia) | TTE (LA size, LVEDD, LV-EF, LVH) | Catheter ablation (type, technique, location, status), pacemaker, ICD implantation (type, indication) | Complications and AEs experienced (specified, date) | Recurrence and rehospitalization since discharge (date, LoS, documentation, CV info., reason) | ||
Other comorbidities | TEE (findings) | Surgery (time, date, location, technique) | Discharge medications (type, dose, indication) | Complications and AEs experienced (specified, date) | ||||
Chest X-Ray, Stress test, Holter ECG, MRI, CT exam | Discharge medications (type, dose, indication) |