22 Stratos LV/LV-T Technical Manual

Enrolled and Randomized Patients

Group 1

43

Group 2

50

Group 3

25

Implant Attempted

 

Group 1

39

Group 2

44

Group 3

21

Successful implant

 

Group 1

33

Group 2

42

Group 3

18

Completed 6-Month Follow-up

Group 1

23

Group 2

30

Group 3

15

No implant Attempted

Withdrawal of Consent

Group 1

2

Group 2

4

Group 3

3

Not Meeting Inclusion Criteria

Group 1

2

Group 2

2

Group 3

1

Unsuccessful implant

Withdrawal of IC before 2nd Attempt

Group 1

4

Group 2

2

Group 3

3

Follow-up to failed implant data pending

Group 1

2

 

Group 2

0

 

Group 3

0

 

 

 

Ablation/Ablation Data Pending

Group 1

3

Group 2

0

Group 3

0

6-Month Follow-up Data

Patient Death before 6-Month

Group 1

0

Group 2

2

Group 3

0

Withdrew before 6-Month FU

Group 1

1

Group 2

1

Group 3

0

Not Reached 6-Month FU or Data Pending

Group 1

6

Group 2

8

Group 3

3

6-month FU Not Completed

 

Group 1

0

Group 2

1

Group 3

0

Figure 1: Patient AccountabilityDemographics and Baseline Parameters

Table 1 provides a summary of the patient demographics at enrollment. There were no statistical differences in enrollment demographics between the 3 groups.