User Manual Part 4

CLINICAL STUDY - CONTAK RENEWA L
E-3
Tab le E-1. Pre-imp lant characteristics of study patient (continued)
Characteristics
a
Patient Data
PR Interval 211 ± 49 ms
Resting HR 70 ± 12 bpm
a. Continuous measures are reported as means ± standard deviations.
VENTRICULAR TACHYARRHYTHMIA DETECTION TIME
The CONTAK RENEWAL device has independent Left Ventricular and Right
Ventricular Sensing. Ventricular tachyarrhythmia detection time was analyzed
to determine if the sensing configuration had any effect on sensing VT/VF.
Based on previous clinical studies of the VENTAK AV family, upon which the
ICD function of CONTAK CD and CONTAK RENEWAL are built, Guidant’s
ICDs typically have a VF detection time of approximately two seconds. The VF
detection time of 2.4 ± 0.5 seconds in the RENEWAL study was statistically
lower than 6 seconds (p < 0.01), demonstrating that there was no s tatistically
significant prolongation of induced VF detection times with the independent
sensing configuration.
1
There were no adverse events reported in which
a CONTAK RENEWAL device failed to detect a spontaneous ventricular
tachyarrhythmia.
HOLTER STUDY - CONTAK RENEWAL
Study Design
The CONTAK RENEWAL Holter Study was a prospective, multi-center,
non-randomized evaluation conducted in Europe, in which 46 patients
completed testing. The purpose of the study was to demonstrate continuous
appropriate biventricular (BiV) pacing over a 24 hour period and during
exercise using Holter m onitor recordings. All patients had been implanted with
a CONTAK RENEWAL for a minimum of one month at the time of the study
initiation.
1. Detection time at implant with legally marketed Guidant ICD devices is typically two seconds,
and investigators have stated than an additional delay of 3 to 5 seconds w ould be a c linically
significant event. The expected detection time is 2 seconds (95% CI: [0, 6 se c]).
- DRAFT -