User Manual Part 4

H-4
CLINICAL STUDY - SUMMARY OF GDT1000 SEN
SING ACUTE STUDY
placed in the septal wall (0/1) and unspecified lo cation (1/0). A majority of
the left ventricular leads were implanted in the lateral, postero-lateral, or
posterior wall (21/15), with the remaining placed in an antero-lateral, anterior,
or postero-septal location (4/3).
Lead Configurations
In this study, both RA and RV leads used a bipolar configuration, which was not
programmable. The LV lead configuration prog ramming was per physician’s
discretio n. In the first phase , 20 patien ts had LV sen sing programmed to the
LVtip>>LVring configuration, four to LVtip>>RVcoil, and one to LVtip>>Can.
In the second phase, 13 patients had LV sensing programmed to the
LVtip>>LVring configuration, and four to LVtip>>RVcoil.
Lead Performance
The lead performance, including pacing threshold, pacing impedance and
sensing amplitude, were measured at implant by a commercially available
Pacing System Analyzer (PSA). The results are provided in the table below
(Table H-2 on page H -4).
Table H-2. Lead performance
Measurement Lead Location
Number of
Leads: Phase 1
Mean ± SD:
Phase 1
Number o f
Leads: Phase 2
Mean ± SD:
Phase 2
Pacing
Impedance (Ω)
Left Ventricle
25 10 34 ± 394 18 779 ± 227
Right Atrium 28 520 ± 161 17 519 ± 112
Right Ventricle 29 816 ± 263 18 649 ± 206
Pacing
Threshold (V)
Left Ventricle
25 1.9 ± 1.4 18 1.3 ± 1.0
Right Atrium 28 1.1 ± 0.7 16 1.2 ± 0.6
Right Ventricle 29 1.0 ± 0.4 18 0.8 ± 0.3
Sensing
Amplitude (mV)
Left Ventricle
25 14.1 ± 7.6 18 13.2 ± 7.3
Right Atrium 28 2.9 ± 1.5 16 3.7 ± 3.3
Right Ventricle 29 12 .3 ± 6.2 18 13.4 ± 7.0
Sensing Performance
In the first phase of the study, a total of 55,207 signals were recorded, including
54,151 appropriate sensed intrinsic and paced beats and 1,056 inappropriate
- DRAFT -