User Manual Part 4

D-1
CLINICAL STUDY - CONTAK CD
APPENDIX D
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 CD Study to demonstrate the safety and
effectiveness of the CONTAK CD system and to demonstrate a reasonable
assurance of the safety and effectiveness of biventricular stimulation, or cardiac
resynchronization therapy (CRT), using the Guidant Model 1822 VENTAK CHF
AICD and Model 1823 CONTA K CD CRT-D along with the EASYTRAK (Models
4510/4511/4512/4513) coronary venous, steroid-eluting, single-electrode
pace/sense lead.
The CONTAK CD Study failed to prospectively demonstrate effectiveness of the
CRT portion of the device. The CONTAK CD Study met the Lead and System
Effectiveness endpoints as well as the Lead and System Safety endpoints.
Subgroup analysis revealed a population of patients that had Class III/IV heart
failure at the time of randomization that appeared to have improvements on
certain functional endpoints, including the Peak VO
2
and the Six-Minute Hall
walk. A second study was performed (Focused Confirmatory Study) using this
subgroup of patients to confirm the effectiveness of CRT.
OBSERVED AD VERSE EVENTS
The VENTAK CHF/CONTAK CD/EASYTRAK Biventricular Pacing Study
(hereafter referred to as the CONTAK CD Study) was a prospective,
randomized, controlled, multicenter, double-blind study conducted at 47 sites in
the U nited States and enrolled a total of 581 patients. Of these, 57 patients
initially underwent a thoracotomy procedure to receive the Guidant Model 1822
VENTAK CHF AICD; 7 patients underwent a repeat procedure to receive an
- DRAFT -