User Manual Part 4

C-1
CLINICAL STUDY - DECREASE HF
APPENDIX C
SUMMARY
The DECREASE-HF study was designed to determine if LV-CRT and LV Offset
are safe and effective as compared to the control treatment (BiV-CRT) in
patients with heart failure and an indication for an implantable cardioverter
defibrillator (ICD). The p rim a ry effectiveness endpoint was a composite of
peak VO
2
and left ventricular end systolic diameter (LVESD). The primary
safety endpoints were heart failure related adverse event free rate and system
related adverse event free rate. The LV Offset arm supports the safety and
effectiveness of the LV Offset feature.
The DECREASE-HF Study design has been previously described in medical
literature.
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STUDY DESIGN
Patients were randomized (1:1:1) to receive one of these three therapies.
Patients who could n ot b e randomized due to their inability to complete baseline
testing or because Expert Ease recommended BiV-CRT were followed for
safety data only in a separate “safety arm.” Available data for all patients were
analyzed by randomization group assignment, regardless of actual therapy
received (i.e., intent t o treat).
The DECREASE-HF clinical investigation used CONTAK RENEWAL 2/4/4HE
devices to study the LV Offset feature as well as other features that are not
available in the CONTAK RENEWAL 1/3/3HE devices. The 2/4/4HE devices
are physically and mechanically identical to the 1/3/3HE devices and they both
contain the LV Offset feature. As such, the data from the DECR EASE-HF
clinical study regarding the LV Offset feature, studied by using the 2/4 /4HE
devices, applies to the CONTAK RENEWAL 1/3/3HE devices. The LV Offset
arm supports the safety and effectiveness of the LV Offset feature.
1
.
D
e Lurgio D, Foster E, Higginbotham M, Larntz K, Saxon L. A Comparison of cardiac
resynchronization by sequential biventricular pacing and left ventricular pacing to simultaneous
biventricular pacing: Rationale and design of the DECREASE-HF clinical trial. J Card Fail.
2005;11(3):233-239
- DRAFT -