Advances in information and telecommunication technology has led to the birth of a radically new medical service based on the remote mobile monitoring of patients with implanted pacemakers, defibrillators, or cardiac resynchronization devices.
This medical device study managed by AmeRuss is designed to evaluate clinical and economic benefits from monitoring of the patient`s condition with the help of remote monitoring technology. The trial will also assist in the development of national guidelines for the monitoring of patients with remote technology in order to prevent complications and iatrogenic effects of pacing.
The study design is an international, open, prospective, multicenter, observational trial.
Participating countries include Russia with the sites across the country (Tomsk, Krasnoyarsk, Saint Petersburg, Astrakhan, Ekaterinburg, Novosibirsk, Kemerovo and Chelyabinsk), and Kazakhstan with the sites in Astana and Almaty.
At the end of November 2015, active sites together enrolled 117 patients in the two countries, 46 of which have successfully reached study completion.
This is a full-service clinical project in which AmeRuss is providing full regulatory and investigational support including performance of all necessary regulatory activities, making submissions to local ethics committees, execution of clinical trial agreements with investigational sites and principal investigators, as well as all activities related to project management, development of project plans, monitoring, logistics in both Russia and Kazakhstan.
Preliminary results of the study including clinical efficacy and practical value of therapy based on remote monitoring of patients will be reported in St. Petersburg at the XII International Congress Cardiostim 2016 in February 2016.