The department of cardiac arrhythmias of the Research Institute of Cardiology, Tomsk Scientific Center, Academy of Medical Sciences of Russian Federation conducted à clinical trial of ELKART ÅÐ LAB to estimate its efficiency and safety for recording of surface, esophageal and endocardial electrograms (heart's electrical function); implementation of various stimulation protocols of different heart's chambers; radiofrequency ablation of normal and abnormal pathways and ectopic focuses.

The trial was conducted by à team of highly qualified specialists of the cardiac arrhythmias department. The department also known, as the Siberian Center of Cardiac Arrhythmias is the only center in Siberia and Far East dedicated to treat complex cardiac arrhythmias.

À total of Ç2Ç patients with different forms of tachycardias and arrhythmias were involved in the trial. AII patients underwent diagnostic and therapeutic interventions. The efficacy of radiofrequency energy application for removal of tachycardias was 89% (from 72% in patients with ventricular arrhythmias to 96% with Wolff-Parkinson-White syndrome). 7 patients required à second procedure to obtain the desired result. Second procedures were ineffective in Ç,4% of patients. There was 0,3% of complications during interventions. There were no cases of fatal outcome.

During the trial we noted ECG and intracardiac electrogram signals to be of very high quality and therefore easy to interpret. The feature of simultaneous recording of ECG and intracardiac electrogram signals including differentially amplified ones from different heart's chambers is very helpful.

ELKART ÅÐ LAB enables to perform à complete protocol of diagnostic pacing with the feature of single and burst of programmed extrastimuli that allows for high reliability of ÅÐ study results. During pacing ECG signal ñàn be recorded simultaneously from the same pacing electrode.

There is à software interface for the radiofrequency generator ELECTROPULSE RF-100TZ that enables to control the generator using an on-screen toolbar and view ablation parameters on à monitor.

ELKART ÅÐ LAB is à high-performance system intended for treatment of main forms of tachycardia. ELKART incorporates amplifiers, à computerized and fully integrated cardiac stimulator and à radiofrequency generator compatible to most catheters of any type (thermister/thermocouple). We are glad to recommend ELKART ÅÐ LAB for wide clinical use.

Professor of Cardiac Surgery
Amiran Sh. Revishvili, M.D.

[original text]