User Manual Part 4

CLINICAL STUDY - C ONTAK CD
D-25
Biventricular ATP Conversion Effectiveness Perform ance––the conversion
rate of induced monomorphic ventricular tachycardia (MVT) was 64% and
that of spontaneous MVT was 88%.
Ventricu l ar Tachyarrhythmia Detec tio n Time––the VENTAK CHF and
CONTAK CD devices sense events from both ventricles simultaneously.
Ventricular tachyarrhythmia detection time was analyzed to determine if the
additional lead had an adverse effect on sensing VT/VF. Guidant’s ICDs
typically have a detection time of two seconds. The VF detection time of 2.1
± 0.6 seconds was statistically significantly lower than 6 seconds (p < 0.01),
demonstrating that there was no statis tically significant prolongation of induced
VF detection times with the additional left ventricular lead
1
.Therewerealso
no adverse events reported in which a VENTAK CHF or CONTAK CD failed to
detect a spontaneous ventricular tachyarrhy thmia.
EASYTRAK Lead and System Safety
EASYTRAK Lead Safety––safety was established using the rate of adverse
events that are either related to the EASYTRAK lead o r to the implant
procedure necessary to place the EASYTRAK lead.
An EASYTRAK lead implant procedure was performed in 517 patients with 448
patients (86.7%) being successfully implanted with the E ASYTRAK lead. The
upper boundary of the 95% confid ence interval was hypothe sized to be less
than 23% at six months (Table D-20 on page D-25).
Tab le D-20. L ead -related adverse e vents at six months
Patient Pop ulation N
Event Rate (%) 95% CI
All Patients 517 12.2
(9.4, 15.0)
NYHA Class III/IV
201 17.4
(12.7, 22.7)
Fifty-three lead-related adverse events were reported during the clinical
investigation of the EASY TR AK lead among the 448 patients who were
implanted with an EASYTR A K lead. Twenty-seven procedure-related adverse
events were reported among the 517 patients who underwent the implant
procedure for an EASYTRAK lead.
2
The overall lead-related adverse event
1. Detection time at implant with legally marketed Guidant ICD devices is typically two seconds,
and investigators have stated that an additional delay of 3 to 5 secon ds would be a clinically
significant event. The expected detection time is 2 seconds (95% CI: [0, 6 se c]).
2. For purpo ses of defining event rates, a denominator of 448 will be used for those adverse
events that pertain to chronically implanted EASYTRAK leads, and a denominator of 517 will
be used for those adverse events that pertain to the implant p rocedure of the EASYTRAK lead.
- DRAFT -