Table 2.
Schedule | Visit 0 baseline | Visit 1 | Visit 2 | Visit 3 | Visits 4, 5 and 6 |
Investigations | 0 months | 1 month±2 week | 2 months±2 weeks | 6 months±2 weeks | 12 months/24 months/36 months ±2 weeks |
Medical history | x | × | × | ||
Clinical events (hospital, tests and so on) | × | × | × | ||
CHA2DS2VASc score | × | × | |||
EHRA SC | × | × | × | × | |
SF-36 and AFEQT | × | × | |||
Physical examination | × | × | |||
Vital signs (BP and HR) | × | × | × | × | |
Treatment adjustment (both for atrial fibrillation and any comorbidities) | × | × | × | × | |
Informed consent, inclusion/exclusion criteria | × | ||||
Randomisation | × | ||||
Clinical laboratory tests (as indicated) | × | × | × | × | |
Study laboratory tests | × | × | × | ||
12-lead ECG | × | × | × | × | |
Holter monitoring. ()=as clinically indicated | (×) | (×) | × | × | |
Echocardiography | × | × | |||
Six-minute walking test | × | × |
AFEQT, the atrial fibrillation effect on quality of life; BP, blood pressure; CHA2DS2VASc score, Score for determining the risk of stroke. Points are given for congestive heart failure (1), hypertension (1), age 75 or above (2), diabetes (1) previous stroke (2), vascular disease (1), age 65-75 (1) and female sex (1); EHRA SC, European heart rhythm association symptom classification; HR, heart rate; SF-36, Short Form-36.