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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.