User Manual Part 4

CLINICAL STUDY - VITALITY
G-3
Table G-1. VITALITY Chronic Study Results (continued)
Automatic Rhythm ID Accuracy (1 month) 97.7%
Manual Rhythm ID Accuracy (1 month) 100%
a. GEE adjusted specificity = 9 3.7%
b. Combined specificity includes both Induced and Spontaneous data.
ACUTE STUDY - VITALITY
The VITALITY ICD was compared to a commercia lly available ICD (VENTAK
PRIZM‚ or VENTAK PRIZM 2 ICD) in an acute (nonimplant) paired study of 50
patients enrolled at nine investigating centers between March 8, 2001 and July
24, 2001. A total of 47 patients were tested with the study device, followed by
a control device at the time of a Guidant commercially approved (VENTAK
PRIZM, model 1851 or V ENTAK PRIZM 2, model 1861) implantation.
The purpose of the acute study was to demonstrate that the addition of an SVT
detection enhancement and brady features did not adversely impact normal
ICD sensing and detection functionality. A total of 50 patients were tested
in nine U.S. centers.
Patients studied
The patients (38 M/9 F) had a mean age of 66 years (range 37 to 90) and
a left ventricular ejection fraction of 32% (range 10% to 62%). Most (40%)
presented with monomorphic ventricular tachycardia (MVT) and nonsustained
VT as their primary arrhythmia. Of the patients studied, 87 percent presented
with coronary artery disease or ischemic cardiomyopathy.
Methods and statistics
The acute study was done in the operating room or electrophysiology
laboratory without implantation of the study device. The primary endpoint was
to determine that VT/VF detection time for induced episodes is within two
seconds of the VENTAK PRIZM or VENTAK PRIZM 2 detection time.
Results
A total of 50 patients were enrolled in the acute study. Of those, 47
patients were successfully tested with the system per study protocol; there
were two attempted procedures and one intent. There was one clinical
complication and two observations reported in the acute study, all of which
were non-investigational device related. No patient deaths were reported.
- DRAFT -