Up to 50 percent of people with advanced heart failure develop abnormalities of the heart s electrical impulses, which disturb the timing of the contractions of the heart s two lower chambers, called ventricles, so that they do not contract simultaneously. When this occurs, the symptoms of heart failure, including shortness of breath, fatigue and swelling of the feet and ankles, may worsen, thereby decreasing the pumping efficiency of the heart. We will investigate if this therapeutic approach improves the quality of life for patients with heart failure.
Heart failure affects about five million people in the United States.
This debilitating disease is the most frequent cause of hospitalization for people age 65 and older, and often leads to premature death. The main purpose of the study is to assess the safety and effectiveness of the device in patients with heart failure who are also indicated for a traditional defibrillator and meet the other entry criteria. The study will involve up to 35 investigational centers in the U.S. and will enroll 300 participants nationwide. Only a small incision is required to implant the device. The procedures takes about two to three hours to perform and requires patients to stay in the hospital overnight.