PROCEDURE | VISIT | ||||||
---|---|---|---|---|---|---|---|
Enrollment | Baseline | Ablation | Discharge | 1 month | 6 months | 12 months | |
Eligibility screen | ✓ | ||||||
Informed consent | ✓ | ||||||
Demographic Data | ✓ | ||||||
Medical History | ✓ | ||||||
QoL assessment | ✓ | ✓ | |||||
Medication | ✓ | ✓ | ✓ | ✓ | ✓ | ||
12-lead ECG | ✓ | ✓ | ✓ | ✓ | ✓ | ||
CMR (gr. 1 and 2) | ✓ | ||||||
TTE | ✓ | ✓ | ✓ | ||||
Cardiac CT (gr. 1 and 2) | ✓ | ||||||
ICD check | ✓ | ✓ | ✓ | ✓ | |||
Ablation data | ✓ | ||||||
Safety data | ✓ | ✓ | ✓ | ✓ | ✓ | ||
Protocol Deviation | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
Adverse event | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
Termination | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |