Medtronic, Inc. (NYSE: MDT) announces completion of the enrollment phase of 1,800 patients in the RAFT clinical trial (Resynchronization/Defibrillation for Ambulatory Heart Failure Trial), which is studying the impact of cardiac resynchronization therapy in mildly symptomatic heart failure patients, or those at risk of worsening heart failure, but not currently indicated under medical guidelines to receive treatment with the device.
“This study is important to guide therapy for heart failure patients with milder heart failure symptoms who have a dilated heart and poor heart function. These patients have a tendency to develop worsening symptoms, to require hospitalization, and they may die prematurely. This study will determine if cardiac resynchronization therapy, when used earlier in the disease, can delay or prevent the progression of heart failure,” said Anthony Tang, M.D., RAFT Nominated Principal Investigator and Adjunct Professor of Medicine, University of Ottawa.
More than 22 million people worldwide – including 500,000 Canadians and 5 million Americans – have heart failure, a condition in which the heart cannot adequately pump blood to the body. Cardiac resynchronization therapy is a proven treatment for some patients with moderate to severe heart failure (New York Heart Association, or NYHA Class III and ambulatory Class IV) that improves the heart’s pumping efficiency, may help to reduce heart failure symptoms as well as hospitalizations, and may improve quality of life and reduce mortality. The RAFT trial is one of several clinical trials underway to determine whether patients with mild or fewer symptoms (NYHA Class II) also may benefit from cardiac resynchronization therapy.
“Medtronic-sponsored research has demonstrated the utility of cardiac device therapy in heart failure patients,” said Marshall Stanton, M.D., vice president of clinical research for the Cardiac Rhythm Disease Management business at Medtronic. “The aim of these efforts is to ensure more heart failure patients who could benefit from our therapies are able to receive them.”
A double-blinded, randomized, controlled trial, RAFT is led by the University of Ottawa Heart Institute and jointly supported by a peer reviewed grant from Medtronic and the Canadian Institutes of Health Research (CIHR). It involves 1,800 patients with mild to moderate heart failure (NYHA Class II and III), left ventricular ejection fraction (LVEF, a measure of the heart’s pumping effectiveness) less than or equal to 30 percent and QRS duration of greater than or equal to 120 milliseconds. Patients in the control group received either a single or dual chamber ICD; patients in the “experimental” arm received a cardiac resynchronization therapy-defibrillator. The primary outcome is a composite of total mortality and heart failure hospitalization; secondary outcomes include total mortality, cardiovascular mortality, sudden arrhythmic death, health related quality of life, and cost economics. Patients will be followed for a minimum of 18 months.
About Heart Failure and Cardiac Resynchronization Therapy
– Heart failure is a major economic burden, with the high incidence of hospitalizations as a major cost driver. Estimates place the cost of treating Canadian patients with moderate to severe heart failure at up to $2.3 billion CAD annually1. In the United States, it costs $34.5 billion annually2.
– Chronic heart failure occurs when the heart is unable to pump enough blood to sustain adequate circulation in the body’s tissues.
– The initial manifestation in heart failure is a decrease in blood output from the left ventricle. In many cases, this decrease in pumping output is accompanied by errant impulses from the heart’s electrical system. These can result in accelerated rhythms that adversely affect the heart’s ability to pump blood and are potentially lethal.
– Cardiac resynchronization therapy uses an implantable device to improve the pumping efficiency of the heart and increase blood flow to the body.
– Cardiac resynchronization therapy is intended to complement standard drug therapy, and dietary and lifestyle modifications.
– Some heart failure patients may also be at risk for sudden cardiac death and are eligible to receive an implantable-cardioverter defibrillator (ICD), a device that uses electrical impulses to stop fatal heart rhythms, or a combination cardiac resynchronization therapy defibrillator. Recent studies have shown that ICD therapy significantly reduces death from sudden cardiac arrest in patients with heart failure and poor heart pumping function.
Caution: Similar studies to RAFT, using CRT devices in this patient population, are being conducted in the United States. The use of CRT devices is limited by federal (or United States) law for this indication.
Medtronic, Inc. , headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s Annual Report on Form 10-K for the year ended April 25, 2008. Actual results may differ materially from anticipated results.
1 J.D. Bentkover et al. New technologies and potential cost savings related to morbidity and mortality reduction in Class III/IV heart failure patients in Canada. International Journal of Cardiology; 88(2003) 33-41.