A $3.5 million, three-and-a-half-year-study, will gather data from 3,500 patients with implantable cardioverter-defibrillators (ICDs) to analyze the risks and benefits associated with ICDs in patients who are at risk of death from ventricular fibrillation.
Ventricular fibrillation is an abnormal heart rhythm that can cause the cardiac muscles in the ventricles to tremble. If prolonged, the arrhythmia can promote sudden cardiac death in patients.
The research, supported by the Department of Health & Human Services (HHS), the Agency for Healthcare Research and Quality (AHRQ) and the American College of Cardiology (ACC), is being conducted in conjunction with the National Heart, Lung and Blood Institute within the HHS.
Typically, ICDs deliver an electric shock to restore normal rhythm when potentially life-threatening rhythms are detected. During the study, researchers will examine how often ICDs deliver shocks, whether shocks are appropriate and identify patients who are most likely to require ICD shocks.
During the study’s first two years, AHRQ will provide $2.1 million to conduct the study sample and collect ICD shock data. The ACC will put forth $1.4 million to collect and analyze shock data during the remainder of the study.
"This study will provide critically important data from the real world of everyday medicine to inform discussions about the long-term benefits of ICD use," said Carolyn M. Clancy, MD, director of AHRQ.
The research will be led by Fred Masoudi, MD, MSPH, an associate professor of medicine at the Denver Health Medical Center’s division of cardiology, and Robert Greenlee, PhD, MPH, research scientist at the Marshfield Clinic Research Foundation’s Epidemiology Research Center in Wisconsin.