User Manual Part 4

E-1
CLINICAL STUDY - CONTAK RENEWAL
APPENDIX E
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.)
SUMMARY
Guidant conducted the CONTAK RENEWAL Study, which demonstrated the
device’s ability to app ro p ria tely detect ventricular tachyarrhythmias with an
independent sensing configuration. Finally, the CONTAK RENEWAL Holter
Study was conducted to provide confirmation of the device’s ability to provide
continuous biventricular pacing on both a daily basis and during exercise.
STUDY DESIGN
The CONTAK RENEWAL Study was a prospective, multi-center,
non-randomized evaluation conducted in Europe and enrolled a total of 45
patients. The purpose of t he study was to verify that the CONTA K RENEWAL
device performs according to specification.
INCLUSION/EXCLUSION CRITERIA
Patients who were enrolled in the study were required to meet the following
inclusion criteria:
• Symptomatic heart failure
• Left ventricular dysfunction
•WideQRS
• At risk for sudden cardiac death
• 18 years or of legal age in order to give informed consent according to
national laws
- DRAFT -