The study is also being conducted at 19 other medical centers around the country. CHF affects about 3 million people in the U. S. Of the 3 million, it is estimated that about 70,000 patients could benefit from a transplant. These patients are treated with pharmacological agents, surgery, nutrition, and lifestyle changes to reduce the symptoms associated with heart failure and to improve heart function.
All eligible patients have an equal chance of being assigned to either of the two treatment groups.
LVADs, like the one being studied in this study, have been approved by the Food and Drug Administration only for short-term temporary use by patients who have been approved for heart transplant, while waiting for a donor heart. Optimal Medical Management will be provided under the care and supervision of cardiologists who specialize in the treatment of congestive heart failure. The implantation of the LVAD will be performed in the operating room by a specially trained cardiovascular surgeon and his team. Inc. During surgery, the device will be attached to the left ventricle of the patient's own heart, taking over most of the pumping function for the natural heart that may be too damaged or too weak to beat adequately on its own. This procedure also allows the natural heart to remain in place, thereby taking advantage of the patient's own biological control systems, particularly the regulation of blood flow.