User Manual Part 4

H-1
CLINICAL STUDY - SUMMARY OF GDT1000 SENSING ACUTE
STUDY
APPENDIX H
CLINICAL STUDY POPULATIONS
GDT1000 study included patients indic ated for a CRT-D device. Excluded from
the study were patients meeting any of the following criteria:
• Having no intrinsic P and/o r R wave s at implant
• Having a pre-existing unipolar pacemaker that was not to be
explanted/abandoned
• Enrolled in a concurrent study that would confound the study results
• Having ventricular tachyarrhythmias associated with a reversible cause
(e.g., digitalis toxicity, hypoxia, sepsis, transient electrolyte imbalance,
acute myocardial infarction, electrocution, or drowning)
• Women who were pregnant or planned to become pregnant
• Having a prosthetic mechanical tricuspid heart valve
STUDY METHODS
This clinical investigation was a 50 patient, multi-center, acute study conducted
at seven (7) centers in the United States. The main purpose of this clinical
investigation was to characterize the performance of the new Automatic Gain
Control (AGC) sensing platform, with the Dynamic Noise Adjustment (DNA)
feature, that is used in both COGNIS and TELIGEN devices. The AGC
sensing platform was studied using a Gu id ant A cu te Sensin g Device (GASD )
system, a non-implantable device containing the COGNIS/TELIGEN system
board, hardware, and firmware required for sensing intracardiac signals. The
study enrolled a total of 50 patients and was conducted in two phases. In the
first phase, 28 of 30 patients completed protocol testing. The algorithm was
modified after t he first phase, and it was re-evaluated in the second phase, in
which 17 of 20 patients completed protocol testing. Of the five patients who
did not complete testing in the two phases, three were attempts, and two were
intents.
- DRAFT -