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.
BACKGROUND
The first generation of cardiac resynchronization therapy (CRT) devices approved for the treatment of heart failure used simultaneous biventricular (BiV) pacing to achieve ventricular resynchronization. Left ventricular pacing alone and sequential BiV pacing also show promise as alternative ways to deliver CRT, but have not been studied together in a large randomized trial.


METHODS
The Device Evaluation of CONTAK RENEWAL 2 and EASYTRAK 2: Assessment of Safety and Effectiveness in Heart Failure (DECREASE-HF) Trial is a randomized, double-blind, 3-arm study of patients in New York Heart Association Class III or IV with an ejection fraction of 35% or less and a QRS duration > or =150 ms. Patients are randomized to receive either left ventricular pacing, simultaneous BiV pacing, or sequential BiV pacing.


CONCLUSIONS
The study uses a novel composite endpoint that combines peak oxygen consumption and left ventricular end systolic dimension, thus combining a measure of symptomatic improvement (peak oxygen consumption) with a physiologic measure of ventricular reverse remodeling (left ventricular end systolic dimension) into a single composite score. Additionally, the safety and effectiveness of the CONTAK RENEWAL 2/4/4HE/EASYTRAK 2 system will be evaluated using: heart failure-related adverse events; system-related complications; left ventricular lead-related complications; detection time of induced ventricular fibrillation; and left ventricular lead performance (pacing threshold, pacing impedance, and R-wave amplitude).
De Lurgio
David B
DB
Carlyle Fraser Heart Center, Division of Cardiology, Emory University School of Medicine, Atlanta, GA 30365, USA.
Foster
Elyse
E
Higginbotham
Michael B
MB
Larntz
Kinley
K
Saxon
Leslie A
LA
D002302:Cardiac Output / Q000502:physiology; D002304:Cardiac Pacing, Artificial / Q000379:methods*; D004311:Double-Blind Method; D004452:Echocardiography; D005080:Exercise Test; D006333:Heart Failure / Q000503:physiopathology / Q000628:therapy*; D006801:Humans; D010101:Oxygen Consumption / Q000502:physiology; D018579:Patient Selection; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic / Q000379:methods; D018487:Ventricular Dysfunction, Left / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000628:therapy*; D020257:Ventricular Remodeling / Q000502:physiology