User Manual Part 4

G-1
CLINICAL STUDY - VITALITY
APPENDIX G
CLINICAL STUDY POPULATIONS
Guidant CRT-Ds, when compared to OPT alone, have been demonstrated with
reasonable assurance, to be safe and effective in significantly reducing: the
risk of a compos ite of all-cause mortality o r first hospitalization by 20%, the
risk of all-cause mortality by 36%, and heart failure symptoms in patients who
have moderate to severe heart failure (NYHA III/IV ) including left ventricular
dysfunction (EF ≤ 35%) and QRS duration ≥120 ms and remain symptomatic
despite stable, optimal heart failure drug therapy, based on the Guidant
sponsored COMPANION clinical study. (Guidant devices were the only devices
studied in the CO M PANION clinical trial.)
CHRONIC IMPLANT STUDY - VITALITY
The purpose of this study was to evaluate the safety and effectiveness of
Guidant VITALITY family devices with Automatic Intrinsic Rhythm ID. This
clinical study was a single-arm, prospective, multi-center study. There were
a total of 100 patients enrolled at 21 US investigational centers between
December 3, 2002 and January 10, 2003.
Patient Population
One hundred patients were enrolled in this study and 96 patients received
investigational devices. The mean age of the patients implanted with the
VITALITY device was 67.3 ± 10.8 years old. The mean left ventricular ejection
fraction was 30.4% (range 11.0% - 71.0%). S eventy-eight (78) patients (81.3%)
were male. The primary cardiovascular disease (42.1%) was coronary artery
disease (CAD) and the primary tachyarrhythmia (38.5%) was monomorphic
ventricular tachycardia (MVT).
Methods
A prospective, multi-center, nonrandomized clinical study evaluated the safety
and effectiveness of the VITALITY device in humans. Ninety-six patients
selected from the investigator’s general patient population who met the
indications for use of the VITALITY device were followed through pre-discharge,
2-week and 1-month follow-ups and continued every 3 months thereafter until
study closure.
- DRAFT -