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University of Rochester Leads Worldwide Heart Research Project

Clinical Study Tests Newer Type of Implanted Defibrillator

Tuesday, November 23, 2004

Arthur J. Moss, M.D., one of the nation’s leading cardiologists and a professor of Medicine at the University of Rochester, is leading a multi-million dollar, five-year project to study a new generation of implanted defibrillators. The research focuses on preventing heart failure progression in patients with early-stage heart disease, with a pager-sized device that correctly synchronizes the heart’s contractions.

“The implications of this unique therapy are profound because it focuses not on treatment alone, but more importantly, on preventing heart disease progression,” Moss says.

For a decade Moss has amassed a body of randomized, clinical scientific data that showed the life-saving benefits of implantable cardioverter defibrillators (ICDs) made by Guidant Corporation. This is Moss’ third major study of the ICD, with the two prior studies involving more than 1,400 research volunteers. Each time he incorporates a larger or different group of patients who might benefit at the earliest possible point in their disease progression. 

The latest study, called MADIT-CRT (Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy) will take place at 78 medical centers in the U.S. and 15 in Canada and Europe. Doctors hope to enroll 1,800 patients, and the trial will begin in December 2004. The U.S. Food and Drug Administration approved the protocol.

Patients will receive either an implantable cardiac resynchronization device with defibrillator capability or only an implantable defibrillator; both groups will receive optimal medical care. The cardiac resynchronization device with defibrillator capability can not only disrupt a potentially fatal fast heart rhythm, but it also can synchronize the heart’s lower chambers to help the heart pump more efficiently. This approach allows researchers to study whether resynchronization can improve the mechanical function of the heart and prevent or slow the progression of heart failure.

 In the first study, Moss evaluated the life-saving potential of the implantable defibrillator. In the Guidant-sponsored trial, called the Multicenter Automatic Defibrillator Implantation Trial (MADIT), published in 1996, Moss showed that in high-risk heart patients the defibrillator worked as it was supposed to, shocking the heart back into a normal rhythm when it began beating dangerously fast and erratically. Patients with the ICD lived longer than those who did not receive an ICD. Trial results showed a 54 percent reduction in risk of death from all causes in patients receiving an ICD.

 In a later study, published in 2002 from the Guidant-sponsored MADIT II trial, Moss showed for the first time that implantable defibrillators could be used to improve survival in people who had a prior heart attack and had impaired heart function. The MADIT II results showed a 31 percent reduction in death from any cause for ICD-treated patients, thus paving the way for prophylactic ICD implantation in patients at risk of sudden cardiac death.

The important work of MADIT, MADIT II and other clinical trials using an ICD created a solid foundation for this latest investigation. Guidant is the sole sponsor of the MADIT-CRT study.  Funding is provided exclusively to the University of Rochester through an independent research grant. Dr. Moss and his team at the University of Rochester Medical Center will direct the study, and he will supervise scientific data analysis, safety monitoring, and publication of the study results.

“We are trying to advance the science of cardiology, while also improving the human condition, by reducing the incidence of late-stage heart failure,” Moss says. “This is exactly the kind of work that the University of Rochester Medical Center has always been committed to doing. It fits very nicely with our goals and overall mission.”

Heart failure is the leading cause of hospitalizations in the United States. It can be caused by damage to the organ after a heart attack, or from a virus. Cardiologists diagnose about 500,000 new cases each year, and a reservoir of about five million patients with heart failure exists at any given time.

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