Timepoint/stages | Study Period | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Baseline | Intervention | 24 h | 7 days ± | 4 weeks ± 3 days | 8 weeks ± 5 days (Telephone) | 16 weeks (4 months) ± 10 days | 6 months ± 10 days (Telephone) | 8 months ± 10 days | 12 months ± 10 days (Telephone) | |
Enrollment | ||||||||||
Informed consent | X | |||||||||
Clinical history and exploration | X | |||||||||
Eligibility screen | X | |||||||||
Allocation | X | |||||||||
Intervention | ||||||||||
Implantation | X | |||||||||
Removal | X | |||||||||
INR | X | |||||||||
Assessments: | ||||||||||
Blood test | X | X | X | X | X | |||||
Imaging test | X | X | X | Xa | X | X | ||||
Symptomatology | X | X | X | X | X | X | X | X | X | |
Visit | X | X | X | X | ||||||
Telephone contact | X | X | X | X | ||||||
Adverse effects | X | X | X | X | X | X | X | X | X | X |
Primary outcome | X | |||||||||
Secondary outcomes | X | |||||||||
Medication | X | X | X | X | X | X | X | X | X | X |