Healthcare Industry News: remote monitoring
News Release - July 23, 2007
BIOTRONIK Announces the 1000th Enrollment in the TRUST Clinical Study
LAKE OSWEGO, Ore.--(HSMN NewsFeed)--BIOTRONIK today announced that on Friday, July 20, 2007, it enrolled the 1000th patient in the TRUST Study (Lumos-T Safely RedUceS RouTine Office Device Follow Up). This enrollment, performed at Cleveland Clinic, completes the initial target enrollment of 1000 patients three months ahead of the projected completion timeframe for the study.The TRUST study is a randomized, prospective, multi-center trial. The study was designed by a steering committee comprised of eight prominent Electrophysiologists and is sponsored by BIOTRONIK, Inc. The primary endpoint of this two-arm trial is designed to evaluate whether outcomes in patients with Lumos and Lumax VR-T/DR-T defibrillators followed by Home Monitoring technology and IEGM Online® are at least equivalent if not better than with those followed by the current standard of care (in-person follow-up).
Secondary endpoints include the assessment of Home Monitoring and IEGM Online® for early notification of asymptomatic events and to triage patient-initiated device inquiries. Recently, the TRUST study was amended to formally evaluate the trial's pre-specified secondary endpoint. The focus of this amendment will be on the assessment of early detection of cardiac events such as VT, VF and AF. To obtain appropriate statistical power, the enrollment level has been increased to 1515 patients. However, the evaluation of the primary endpoint will still occur when the 1000th patient has completed the study follow-up period.
"This is an exciting moment. The completion of enrollment in TRUST ahead of schedule points to the enthusiasm with which this ICD trial has been greeted. We are implanting ICD's at a time when follow-up volumes are straining our clinic capacity, though most visits require no action since devices are largely implanted for prophylactic indications. There has been a call for remote monitoring and TRUST is the first to test remote monitoring technology in a large scale prospective clinical trial. The study's goal is to demonstrate that "Home Monitoring" can streamline office visits and yet improve surveillance power for important device- or patient-related clinical data. We are eagerly waiting for the results," stated the National Principal Investigator Niraj Varma, M.D., FRCP, Director, Cardiac EP Laboratories and Associate Professor of Medicine at Loyola University in Chicago.
Home Monitoring and IEGM Online® represent a pioneering advancement in ICD technology. Patient cardiac conditions and device status can be evaluated using a secure internet-based system, without patient intervention. The system can provide notification of critical alterations of the heart rhythm, as well as any potential technical malfunction of the device. Additionally, BIOTRONIK's Lumos and Lumax ICDs are the sole devices of their kind worldwide that can include an IEGM (cardiac electrogram) immediately and automatically with a cardiac event notification. The TRUST study will further evaluate the practical application of these devices and holds promise to change and streamline the future standard of care for ICD follow-up.
"The TRUST study is very important since it will be the first trial reported that evaluates whether the current enthusiasm for home monitoring is as good as or better than in-person follow up with respect to patient safety and outcomes. BIOTRONIK is to be commended for taking a leadership role in this area," commented participating Principal Investigator Andrew Epstein, M.D., FAHA, FACC, Professor of Medicine at the University of Alabama at Birmingham.
BIOTRONIK today ranks as one of the leading cardiac rhythm management (CRM) companies, conducting business in over 100 countries worldwide. BIOTRONIK provides complete solutions for diagnosis, treatment and highly developed therapy management in the field of cardiac rhythm management.
Source: BIOTRONIK
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