Towards virtual laboratory for optimal patient-specific cardiac resynchronization

描述（由申请人提供）：CardioSolv Ablation Technologies, Inc.旨在开发并商业化一种基于模拟的方法，用于无创预测梗死相关性室性心动过速患者导管消融的最佳靶点。商业化的成功完成将导致室性心动过速消融临床程序的重大范式转变，在临床程序之前，CardioSolv的方法将准确预测每个患者心脏的最佳消融目标。在这些预测的指导下，消融的递送将迅速而精确地消除所有梗死相关的室性心动过速，病灶面积最小。这将显著提高治疗的疗效和耐受性，并减少术后并发症。该项目的目的是将我们的基于模拟的消融指南作为商业级软件医疗设备，准备获得监管部门的批准。为了实现这一目标，CardioSolv将开发软件，同时遵循全球监管机构要求的严格质量程序。在整个开发过程中，测试将确保所有证明该方法的初步结果将被最终的商业产品所复制。

DESCRIPTION (provided by applicant): CardioSolv Ablation Technologies, Inc. aims to develop and commercialize a simulation-based approach for non-invasive prediction of the optimal targets of catheter ablation in patients with infarct-related ventricular tachycardia. Successful completion of the commercialization will result in a major paradigm shift in the clinical procedure of ventricular tachycardia ablation, where accurate prediction of the optimal targets of ablation in each patient heart will be carried out by CardioSolv's methodology prior to the clinical procedure. Guided by these predictions, delivery of ablation will be swift and precise eradicating all infarct-related ventricular tachycardias with minimum lesion sizes. This will resul in a dramatic improvement in the efficacy of and tolerance for the therapy, as well as in reduction of post-procedure complications. The aim of this project is to implement our simulation-based ablation guidance as a commercial-grade software medical device ready for regulatory approval. To achieve this aim, CardioSolv will develop the software while following the strict quality procedures required by global regulatory bodies. Throughout development, testing will ensure that all preliminary results proving the methodology will be replicated by the final commercial product.