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22 Stratos LV/LV-T Technical Manual
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
Enrolled and Randomized Patients
Group 1 43
Group 2 50
Group 3 25
Implant Attempted
Group 1 39
Group 2 44
Group 3 21
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
Successful implant
Group 1 33
Group 2 42
Group 3 18
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
Completed 6-Month Follow-up
Group 1 23
Group 2 30
Group 3 15
Figure 1: Patient Accountability
Demographics 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.