Stratos LV/LV-T Technical Manual 53

Enrolled and Randomized

Patients

Study 133

Control 67

Implant Attempted

Study

130

Control

65

Successful implant

Study

129

Control

64

Patients completed 6-Month

Follow-up

Study 100

Control 49

No implant Attempted

Withdrawal of Consent

Study

2

Control

1

Not Meeting Inclusion Criteria

Study

1

Control

1

Unsuccessful implant

Withdrawal of IC before 2nd Attempt

Study 1

Control 0 Expired before Second Attempt

Study 0

Control 1

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

Figure 2: Patient Accountability

Demographics and Baseline Parameters

Table 13 provides a summary of the pre-enrollment demographics of enrolled patients.