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First CRT-D Patient Enrolled in the EuroEco ICD/CRT-D Trial

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BIOTRONIK has announced that the first CRT-D patient has been enrolled in the BIOTRONIK EuroEco Trial-the European Health Economic Trial on Home Monitoring in implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy device (CRT-D) patients.

The aim of the study is to assess the economic effects of BIOTRONIK Home Monitoring® based remote follow-up management compared to conventional in-clinic or practice follow-ups.

In the study, the economic impact on the hospital - expressed as total follow-up cost - will be assessed and the cost-effectiveness will also be evaluated as a secondary analysis.

The trial has been extended to incorporate CRT-D patients after more than 300 ICD patients enrolled in the first stage of the trial.

BIOTRONIK Home Monitoring® is a unique system that provides continuous, automatic, wireless remote monitoring of patient status and device status with daily updates-all independent of any patient interaction.

The landmark trial TRUST1,2 and the COMPAS3 study have proven that BIOTRONIK Home Monitoring® leads to early detection of clinically relevant events and therefore to an earlier intervention and reduction of hospitalizations.

“Studies on the economic effects of remote follow-ups are still sparse,” remarked Prof. Dr. Hein Heidbüchel, Cardiology, University Hospital Leuven, Belgium, and Coordinating Clinical Investigator of the trial.

“Nevertheless, the financial implications of remote care will drive its acceptance. Authorities and hospitals will need information on how this innovative care can be adequately reimbursed. EuroEco is the first trial where an economic evaluation of remote monitoring is the primary endpoint.”

“The medical benefit-the safety and efficiency of BIOTRONIK Home Monitoring®-has already been proven,” continued Prof. Heidbüchel. “With the efficiency and safety this service offers, we postulate that BIOTRONIK Home Monitoring® also provides ways of improving care in a cost-effective way, which constitutes a win for patients, a win for society and a win for health care providers.”

The EuroEco trial is a randomized, multicenter, international clinical trial with 312 ICD patients, and in its extension 104 CRT-D patients-a total of 416 patients in 15 European sites- with each patient having a 24-month follow-up.

“The BIOTRONIK Home Monitoring® remote follow-ups are able to enhance the safety and quality of patients’ lives by allowing for earlier detection of clinically relevant events and avoiding hospitalizations,” commented Christoph Böhmer, President International at BIOTRONIK.

Böhmer continued, “We can proceed from the assumption that the systematic and continuous remote monitoring with BIOTRONIK Home Monitoring® will have clear effects on cost effectiveness and savings for the health care system.”