Table 3.
DETERMINE TRIAL: Follow up
| Screening Baseline | Post Randomization (Months) | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 3 | 6 | 9 | 12 | 15 | 18 | 21 | 24 | 27 | 30 | 33 | 36 | 39 | 42 | 45 | 48 | ||
| Medical History | X | ||||||||||||||||
| Physical Exam | X | X | X | X | X | X | X | X | X | ||||||||
| MRI data | X | ||||||||||||||||
| ICD Interrogation | X | X | X | X | X | X | X | X | |||||||||
| Medications | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X |
| 12-Lead ECG | X | X | X | X | X | ||||||||||||
| 6 Minute Walk Test | X | X | X | X | X | ||||||||||||
| QOL Questionnaire | X | X | X | X | X | X | X | X | X | ||||||||
| Genetic Sample | X | ||||||||||||||||
| Adverse Events | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | |
| Telephone Contact (vital status) | X | X | X | X | X | X | X | X | |||||||||
All patients will continue the follow-up schedule (every 6 months clinic visit alternating with telephone follow-up) until the last randomized patient has been followed for 24 months.