Mintek LV Manuale Utente
Stratos LV/LV-T Technical Manual 53
Enrolled and Randomized
Patients
Study
133
Control
67
No implant Attempted
Withdrawal of Consent
Study
2
Control
1
Not Meeting Inclusion Criteria
Study
1
Control
1
Implant Attempted
Study
130
Control
65
Unsuccessful implant
Withdrawal of IC before 2nd Attempt
Study
1
Control
0
Expired before Second Attempt
Study
0
Control
1
Successful implant
Study
129
Control
64
6-Month Follow-up Data
Patient Death before 6-Month
Study
7
Control
3
Withdrawal before 6-Month
Study
1
Control
2
Not Reached 6-Month FU
or Data Pending
Study
21
Control
10
Patients completed 6-Month
Follow-up
Study
100
Control
49
Figure 2: Patient Accountability
Demographics and Baseline Parameters
Table 13
provides a summary of the pre-enrollment
demographics of enrolled patients.