Table 1.
Study phases | |||||||||
---|---|---|---|---|---|---|---|---|---|
Screening and enrolment | Pre-treatment | Radioablation | Post-treatment (until discharge) | 1 month FU | 3 months FU | 6 months FU | 12 months FU | ||
Study activities | Compliance with inclusion/exclusion criteria | X | |||||||
Informed consent | X | ||||||||
Anamnesis | X | ||||||||
Physical examination | X | X | |||||||
Laboratory tests | X | X | |||||||
Thorax RX | X | ||||||||
Echocardiogram | X | X | X | X | X | ||||
12-lead ECG | X | X | X | X | X | ||||
ICD interrogation | X | X | X | X | X | X | |||
Other routine patient-related exams | X | X | |||||||
QoL evaluation | X | X | X | X | |||||
Cardiac CT | X | ||||||||
Electroanatomical mapping | X* | ||||||||
Simulation thorax CT and target and OARs definition | X | ||||||||
Treatment planning elaboration | X | ||||||||
Radioablation | X | ||||||||
Weekly phone contact | X | ||||||||
Cardiological visit | X | X | X | X | |||||
Radiotherapy visit | X | X | |||||||
Thorax CT | X | X | |||||||
Adverse effects evaluation | X | X | X | X | X | X |
*To be performed unless already in possess of necessary diagnostic information
CT computed tomography; ECG electrocardiogram; FU follow up; ICD implantable cardioverter defibrillator; QoL quality of life; RX radiography