Nov. 1, 1999 ROCHESTER, MINN. -- Mayo Clinic cardiologists are investigating the use of a new pacemaker-defibrillator device that may offer new hope for patients with heart failure who also have potentially dangerous uncoordinated or irregular contractions of the heart.
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.
"This device delivers small electrical impulses to the left and right chambers of the heart, to better synchronize the contractions of the heart's lower chambers," says Mayo Clinic cardiologist and study investigator, Paul Friedman, M.D. "We will investigate if this therapeutic approach improves the quality of life for patients with heart failure."
Until now, traditional heart failure therapies have included: medications, lifestyle modifications and heart transplant.
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. Healthcare costs associated with caring for those with heart failure in the United States is nearly $10 billion annually.
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.
The device, which is the size of a small pager (66 cc), is implanted under the skin in the chest area, and three thin wires (called leads) are run through veins from the device to the left and right chambers of the heart. 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.
Candidates for the study must have had at least one episode of cardiac arrest manifested by loss of consciousness due to an irregular heart beat, or have fast heart beats from the lower chambers (ventricular tachyarrhythmias). Some individuals who have pre-existing defibrillators in need of change out may also be eligible. Study participants are monitored at one month, three months, six months and every six months thereafter.
The study is expected to last between 12 and 24 months. Patients who are interested in participating in the study should contact electrophysiology clinical research at 507-255-3175 or 507-255-3177.
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