Anticoagulum Cardiac RF Ablation Catheter (Direct Phase II)

DESCRIPTION provided by applicant Radio Frequency RF catheter ablation for atrial fibrillation AF may prevent stroke but paradoxically the procedure itself can cause stroke or other ischemic cerebrovascular events Cognitive dysfunction may arise in to of cases after cardiac ablation procedures and MRI studies have identified between and incidences of andquot silentandquot ischemic lesions in the brain after ablation Thromboembolic risks exist during many other procedures involving intravascular devices For example vascular sheaths catheters and other devices may benefit from technology preventing blood clots forming on blood contacting surfaces FocusStart has developed such a technology and has shown that application of a small negative charge successfully reduces coagulum formation on non irrigated and irrigated RF ablation electrodes during cardiac ablation in vivo via a fibrinogen repelling mechanism This technology could be used as an add on device for all RF ablation catheters with the goal to reduce coagulum formation and subsequent thromboembolic events The negative charge technology by FocusStart may not only increase the safety of RF ablation procedures but also increase procedural efficacy by enabling physicians to use higher RF energies without the risk of coagulum formation This andquot Direct Phase IIandquot SBIR proposal outlines research and development to bring this coagulum prevention technology to clinical use Aim of the proposal is to study the effects of applying negative charge to cardiac RF ablation electrodes on coagulum formation previously shown and thromboembolic events not previously shown In acute canine left heart RF ablation studies the effects of negative charge application on coagulum formation will be measured via intracardiac echography ICE any systemic thromboembolic events will be assessed simultaneously both via an extracorporal blood loop containing a filter as well as real time via Transcranial Doppler sonography The effects of negative charge application on cerebrovascular events will be assessed in a chronic canine RF ablation model In the chronic model coagulum formation will be measured via ICE thromboembolic events via Transcranial Doppler and any cerebrovascular events will be assessed via neurological behavioral function MRI imaging and histopathology Aim of this proposal is to further develop and validate the negative charge device for regulatory approval and clinical use PUBLIC HEALTH RELEVANCE There is a need to reduce thromboembolic events during cardiac radio frequency RF ablation procedures Coagulum formation on RF catheter electrode tips is a possible source of such events The prototype device developed by FocusStart applies a small negative charge to catheter electrodes Previous testing has shown that the device reduces coagulum formation during RF ablation The present studies aim to not only further validate these findings by correlating reduction of coagulum formation with a reduction of thromboembolic events in acute and chronic animal models but also to further develop and validate the negative charge device for regulatory approval and commercialization