Medtronic Begins Clinical Trial: Cardiac Device Combines Defibrillation And Heart Monitoring
Minneapolis - Medtronic, Inc. announced the launch of a landmark clinical trial for a new heart-failure device that combines the capabilities of an implantable cardioverter defibrillator (ICD) with a new technology that continuously records pressure inside the heart, and can alert physicians to potential heart-failure complications before they worsen.
The investigational device, known as the Chronicle(R) ICD, features both the traditional ICD's ability to restore normal heart rhythm following a dangerously fast heartbeat and the first-ever real-time tracking of pressure inside the heart, body temperature, patient activity and heart rate 24 hours a day. Patients implanted with a Chronicle ICD will transmit that information from home, using a standard phone line, to their physicians who view the recorded data from a secure Web site in their office and then potentially make changes to patients' medications or diet.
"Chronicle ICD represents a fundamental change in the way heart-device makers and cardiologists will address chronic diseases such as heart failure in the years to come," said the clinical trial's principal investigator, Philip B. Adamson, M.D., Director, The Heart Failure Institute at Oklahoma Heart Hospital, Oklahoma City. "It's no longer enough to wait until patients develop symptoms of worsening heart-failure - patients and physicians need technology, like Chronicle ICD, that has the potential to provide an early and accurate indication of deterioration in heart failure status, thereby allowing clinicians to take appropriate preventive measures."
The study seeks to determine the safety, efficacy and functionality of the Chronicle ICD when used in heart-failure patients indicated for ICD therapy. Sponsored by Medtronic, the blinded study is a prospective, randomized, multi-center clinical trial at up to 75 sites in the United States involving approximately 850 patients with mild to moderate heart failure (NYHA Class II and III). Heart failure is a condition in which the heart pumps blood inadequately, leading to reduced blood flow and possible back-up of blood in the veins and lungs. Heart failure can lead to sudden cardiac arrest (SCA), an abrupt loss of heart function caused by a rapid, chaotic disturbance of the heart's natural rhythm that is almost always fatal without defibrillation.
"Chronicle ICD expands the walls of the cardiologist's office" said Eugene Chung, M.D., of the Ohio Heart & Vascular Center and lead investigator for Christ Hospital in Cincinnati, site of the first implant in the Chronicle ICD study. "By continuously recording pressure inside the heart, Chronicle ICD provides heart failure clinicians with a precise and early assessment of the patient's underlying congestion, allowing for immediate treatment changes based on the patient's most up-to-date data. This is data previously only available through invasive testing in a cath lab or ICU. Neither the patient nor the doctor has to wait for the next office visit."
SOURCE: Medtronic, Inc.