A Randomized Controlled Trial to Evaluate the Safety and Efficacy of Cardiac Contractility Modulation
William T. Abraham, Karl-Heinz Kuck, Rochelle L. Goldsmith, JoAnn Lindenfeld, Vivek Y. Reddy, Peter E. Carson, Douglas L. Mann, Benjamin Saville, Helen Parise, Rodrigo Chan, Phi Wiegn, Jeffrey L. Hastings, Andrew J. Kaplan, Frank Edelmann, Lars Luthje, Rami Kahwash, Gery F. Tomassoni, David D. Gutterman, Angela Stagg, Daniel Burkhoff and Gerd Hasenfuß
CCM signals are delivered from an implanted pulse generator connected to the heart via one atrial lead (for p-wave sensing) and two ventricular leads (for sensing timing of local electrical activation and for delivering CCM signals). CCM signal are biphasic pulses delivered during the absolute refractory period. CCM signals impact the biology of the failing muscle local and, over time, distal to the site of signal delivery. These myocardial effects ultimately contribute to favorable clinical effects. CCM = cardiac contractility modulation; MLWHFQ = Minnesota Living With Heart Failure questionnaire; NYHA = New York Heart Association.