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Medtronic starts enrolling its Precede-HF clinical trial

Medtronic : 09 October, 2007  (New Product)
Medtronic has begun enrolling for the Precede-HF clinical trial that will evaluate Medtronic’s proprietary Cardiac Compass and OptiVol Fluid Status Monitoring features to determine whether cardiac trend data may help physicians prevent heart failure hospitalisations.
Cardiac Compass data and OptiVol Fluid Status Monitoring are currently available on some of Medtronic’s newest devices, the Concerto and InSync Sentry cardiac resynchronisation therapy-defibrillators (CRT-Ds) and Virtuoso implantable cardioverter-defibrillator (ICD). Device and physiologic trend data can be accessed remotely via the Medtronic CareLink Network, or during in-office visits for patients with these devices.

The Precede-HF trial (Prospective, Randomised Evaluation of Cardiac Compass with OptiVol in the Early Detection of Decompensation Events for Heart Failure) will enroll up to 2,550 patients at up to 100 centres in the USA and up to 15 centres in Canada. The study aims to determine whether the use of Cardiac Compass with OptiVol Fluid Status Monitoring with standard clinical assessment (Access Arm) will reduce heart failure hospitalisations or deaths compared to standard clinical assessment alone (Control Arm).

Heart failure is the most costly cardiovascular disease in the USA, at an estimated $40 billion per year. Further, there are more than one million hospitalisations in the USA annually with a primary diagnosis of heart failure; more than $14 billion is spent each year just on heart failure hospitalisations. More than five million Americans suffer from heart failure, with more than 500,000 new cases diagnosed annually.

“Proactive patient monitoring is critical to effectively managing heart failure patients,” said William T Abraham, MD, FACP, FACC, professor of medicine and Chief of the Division of Cardiovascular Medicine at The Ohio State University, and principal investigator in the trial. “Long-term trends in physiologic parameters, derived from implantable cardiac devices, may provide an early warning to impending episodes of worsening heart failure. Such technologies represent promising new approaches for effectively monitoring and managing heart failure patients.”

Cardiac Compass trends provide up to 14 months of clinical data, including arrhythmia episodes, therapies delivered, physical activity, heart rate, pacing activity, and intrathoracic impedance (via OptiVol Fluid Trends). These diagnostic and monitoring tools may be useful in the clinical management of patients with heart failure. Medtronic’s OptiVol Fluid Status Monitoring feature measures changes in impedance in the thoracic cavity. Using very low electrical pulses that travel across the chest area encompassing the lungs and heart, the system can measure the level of resistance to the electrical pulses, which may indicate the level of fluid in the chest.

The Precede-HF trial also will investigate the use of OptiVol Patient Alerts, which can be either audible or visual indicators. The OptiVol Patient Alerts are intended to inform the patient of a change in fluid status that may be indicative of worsening heart failure. The data also will be sent remotely and automatically to the clinician, who can then view the trend information via a secure web site.

“A key element of this study is the co-management of patients by heart failure specialists and electrophysiologists, in tandem,” said David Steinhaus, MD, vice president and medical director of the Cardiac Rhythm Disease Management business at Medtronic. “We believe this collaboration, when paired with the exclusive features found on Medtronic implantable cardiac devices will produce tangible outcomes of improved management of heart failure patients.”

The Precede-HF trial is one of several efforts to substantiate the impact of Medtronic’s most advanced devices and features to enable better patient care and reduce unnecessary healthcare costs.

The CONNECT (Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision) Trial, initiated in late 2006, is a randomised, prospective study to demonstrate that Medtronic’s wireless remote management system, consisting of the Medtronic CareLink Network and Monitor, Concerto CRT-D and Virtuoso ICD with Conexus Wireless Telemetry, and CareAlert Monitoring, reduces the time to clinical decision compared to in-office care.

Secondary objectives include a reduction in healthcare utilisation, such as hospitalisations and visits to the emergency department; and characterising the burden of in-office follow-up visits for patients and their families, among other patient quality of life issues.
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