User Manual Part 4

CLINICAL STUDY - SUMMARY OF GDT1000 SEN
SING ACUTE STUDY
H-3
STUDY RESULTS
Patient Characteristics
The table below shows the cha racteristics of the patients implanted or
attempted (Table H-1 on page H-3).
Tab le H-1. All patients implanted or attempted, P ha se 1 and Ph ase 2
Characteristic
Measurement
Phase 1 Result (N=29) Phase 2 Result (N =19)
Age at implant
Mean ± SD
65.8 ± 12.2 68.1 ± 9.6
Range [44.6, 85.5] [51.3, 81.8]
Gender [N (%)]
Female
14 (48.0) 14 (74.0)
Male
15 (52.0) 5 (26.0)
NYHA Class [N (%)]
III
27 (93) 19 (100)
IV
2(7) 0(0)
LVEF (%) Mean ± SD
22.4 ± 7.7 23.5 ± 6.4
Range [10.0, 35.0] [15.0, 35.0]
QRS Duration Mean ± SD
161± 29 149± 30
Range [124, 248] [106, 220]
Cardiac Disease [N (%)]
Nonischemic
Cardiomyopathy
14 (48) 7 (37)
Ischemic C ardiomyopathy,
CAD
10 (34) 9 (47)
Hypertension
3(10) 0(0)
Coronary Artery Disease
(CAD)
1(3) 0(0)
Ischemic C ardiomyopathy,
no CAD
1 (3) 3 (16)
Valvular Heart Disease
0(0) 1(5)
Other 0 (0) 1 (5)
Lead Position
In this study, the position of each lead was per physician’s discretion. A majority
of the atrial leads in the first/second phase of the study were placed in the
right atrial appendage (19/12) with the remaining placed in the lateral wall
(5/2), septal wall (2/3), and unspecified location (1/0). A majority of the right
ventricular leads were implanted in the right ventricular apex, with the remaining
- DRAFT -