Medtronic (Minneapolis) is trying to change the standard of care for managing heart failure patients treated with cardiac resynchronization therapy devices from scheduled in-office visits to continuous monitoring via its CareLink Network.

The company recently reported the first worldwide enrollments in a trial that will compare two disease management strategies for heart failure patients treated with an implantable device for cardiac resynchronization therapy. Monitoring Resynchronization in Cardiac Patients (MORE-CARE) aims to demonstrate that remote monitoring of these patients via the Medtronic CareLink Network is superior to in-office visits alone, in terms of clinical effectiveness and healthcare system utilization.

"The MORE-CARE trial, which is just getting underway, will determine whether the CareLink Network is superior to in-office visits for heart failure patients, but we already have data on CareLink remote monitoring as superior to transtelephonic monitoring and routine office visits for pacemaker patients (via the PREFER trial) in terms of identifying clinically actionable events more quickly," Tracy McNulty, a Medtronic spokeswoman, told Medical Device Daily in an email. "We'd hypothesize that similar advantages will be seen in the MORE-CARE trial, but will have to wait until the data is available to confirm that."

According to Medtronic, more than 22 million people worldwide have heart failure, a chronic condition in which the heart is unable to adequately pump blood throughout the body. The MORE-CARE 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 U.S., Medtronic said, and no U.S. patients will be enrolled in this trial.

McNulty said CareAlert notifications are available for 14 different conditions including atrial fibrillation and low battery and can be custom color-coded by the physician based on the urgency of the condition and the preferred notification method. OptiVol CareAlert notifications are available as an additional notification outside the U.S., she said.

Principal investigators for the MORE-CARE trial are Haran Burri, MD, of University Hospital (Geneva, Switzerland); Aurelio Quesada, MD, of General University Hospital (Valencia, Spain); Massimo Santini and Renato Ricci, MD, both of S. Filippo Neri Hospital (Rome).

First enrollments took place recently under the direction of Burri. "The MORE-CARE trial will assess the efficacy of remote monitoring to enable earlier detection of clinical events, and allow physicians to make appropriate treatment decisions based on patient and device data," he said.

Enrolling up to 1,700 patients at about 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.

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

McNulty said the primary endpoint of Phase I of the MORE-CARE trial is the mean time between a device-detected event onset (such as AT/AF, cardiovascular disease progression, or system issues) and the consequent clinical decision or intervention.

"Medtronic has played a pioneering role in remotely monitoring patients with implanted cardiac devices, and our imprint on improved heart failure treatment through our support of numerous clinical trials is unmatched," said Marshall Stanton, MD, VP of clinical research for the Cardiac Rhythm Disease Management business at Medtronic. "MORE-CARE is the latest in a long history of Medtronic clinical trials that aims to bring better care to heart failure patients."

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 FDA approval in 2004. The company said 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 Centers for Medicare and Medicaid Services has 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, the company noted.

"Major cardiovascular adverse events in patients with heart failure represent a significant concern to the medical community, as they require hospitalizations and may lead to death," McNulty said. "Patients with heart failure are counseled regarding the importance of contacting their clinicians promptly if they experience any changes or worsening of their condition. Early intervention may be a key element in avoiding major cardiovascular events and possible deterioration of the disease progression."

She said that if the MORE-CARE trial succeeds in demonstrating that in heart failure patients treated with cardiac resynchronization therapy devices, the remote monitoring strategy is able to trigger an early intervention to prevent clinical conditions worsening, "this will change the standard of care in the management of these patients, shifting the routine strategy from scheduled in-office visits to continuous monitoring of patients' clinical conditions."