Medtronic: More-Care Trial to Assess Remote Monitoring Impact on Heart Failure Patients and Healthcare Utilization

Jun 26, 2009 (Close-Up Media via COMTEX) -- MDT | Quote | Chart | News | PowerRating -- Medtronic, Inc. has announced the first worldwide enrollments in the More-Care (Monitoring Resynchronization in cardiac Patients) trial, which will compare two disease management strategies for heart failure patients treated with an implantable device for cardiac resynchronization therapy.

More than 22 million people have heart failure, a chronic condition in which the heart is unable to adequately pump blood throughout the body.

According to a release, the trial will utilize Medtronic wireless cardiac resynchronization therapy-defibrillators (CRT-Ds) equipped with OptiVol fluid status monitoring and Medtronic CareAlert Notifications, which are designed to give automatic notification to a physician via text message (SMS), email or a Medtronic CareLink Web site message when certain pre-programmed thresholds are crossed (for example, OptiVol fluid levels or atrial fibrillation burden), without the physician having to see the patient in-office for diagnosis. OptiVol CareAlert notifications are not available in the United States; further, no U.S. patients will be enrolled in this trial.

Enrolling up to 1,700 patients at approximately 80 centers worldwide, the More-Care trial is a prospective, randomized, controlled trial, with an expected duration of approximately four years. One set of patients in the study will have CareAlert Notifications activated for fluid accumulation in the chest area (captured via OptiVol measurements), AT/AF (atrial tachycardia / atrial fibrillation, or irregular heart rhythm) episodes and system integrity issues; the other group of patients will have audible alerts enabled for system integrity issues. The trial is comprised of two phases:

- Short-term evaluation of whether remote patient monitoring of patients with Medtronic CRT-Ds and using the CareLink Network reduces the time from device-detected event onset to clinical decisions for arrhythmias, cardiovascular disease progression and system issues compared to patients receiving only in-office care; and

- Long-term evaluation, which aims to demonstrate that the remote monitoring strategy reduces the occurrence of cardiovascular events since it allows for better follow-up on heart failure disease progression.

OptiVol is found on Medtronic's latest wireless defibrillators (Consulta and Concerto CRT-Ds, Secura and Virtuoso implantable cardioverter-defibrillators, or ICDs), and has been available on Medtronic devices since U.S. Food and Drug Administration approval in 2004. OptiVol fluid status monitoring uses low-level electrical pulses that travel across the thoracic cavity (the chest area encompassing the lungs and heart) to measure the level of resistance, indicating fluid in the chest - a common sign of heart failure. Since normal fluid levels vary from patient to patient, and fluid accumulation can be either slow or rapid, OptiVol's ability to measure fluid status trends over time in conjunction with other key device trends and physiologic measures available in Medtronic's proprietary cardiac Compass Reports can provide the opportunity to intervene before patient symptoms develop.

As of Jan. 1, the U.S. Centers for Medicare and Medicaid Services have begun reimbursing physicians for their time spent monitoring heart failure patients using fluid trend data obtained from Medtronic implantable cardiac devices via CareLink Network remote transmission.

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