Towards virtual laboratory for optimizing cardiac rhythm

迈向优化心律的虚拟实验室

• 批准号: 10204085
• 负责人: Brock Michael Tice
• 金额: $ 87.02万
• 依托单位: CARDIOSOLV ABLATION TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-08-01 至 2022-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10204085
• 关键词: 3-Dimensional; Ablation; Address; Adoption; American; Anatomy; Area; Arrhythmia; Automobile Driving; Cardiac ablation; Catheters; Cicatrix; Clinical; Clinical Data; Clinical Research; Clinical Trials; Clinical Trials Design; Collection; Complex; Computer software; Data; Defibrillators; Devices; Effectiveness; Enrollment; Environment; Europe; Evaluation Studies; Feasibility Studies; Generations; Goals; Health Services Accessibility; Heart; Hemorrhage; Hour; Implant; Implantable Defibrillators; Improve Access; Infarction; Investigation; Journals; Label; Lesion; Life; Location; Longevity; Longterm Follow-up; Maps; Medical Economics; Methodology; Methods; Modeling; Morphology; Myocardial Infarction; Nature; Outcome; Pathway interactions; Patients; Peer Review; Perforation; Phase; Predisposition; Procedures; Public Health; Publications; Quality of life; Radiation; Risk; Safety; Signal Transduction; Survivors; System; Technology; Testing; Tissues; United States; Ventricular Tachycardia; Work; base; commercialization; cost; data exchange; economic impact; experience; healing; heart rhythm; improved; improved outcome; mortality; patient population; primary endpoint; prospective; prototype; secondary endpoint; simulation; structural heart disease; success; virtual; virtual laboratory; virtual model; web interface

PROJECT SUMMARY CardioSolv Ablation Technologies, Inc. has developed and aims to 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 result 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 complete a clinical trial to collect data in support of safety, efficacy, and labeling claims, with the ultimate goal of regulatory clearance to market the device.

项目摘要 Ablation Solv Ablation Technologies，Inc.已经开发并旨在商业化一个基于模拟的 非侵入性预测梗死患者导管消融最佳靶点的方法- 相关的室性心动过速。商业化的成功完成将导致一个重大的 室性心动过速消融术临床程序的范式转变，其中准确预测 每个患者心脏的最佳消融目标将由CIMSOLV的方法来实现 在临床程序之前。在这些预测的指导下，消融的实施将是迅速和精确的， 以最小的病变尺寸根除所有梗死相关的室性心动过速。这将导致 治疗的功效和耐受性的显著改善，以及术后并发症的减少， 手术并发症 该项目的目的是完成一项临床试验，以收集支持安全性、有效性和 标签声明，最终目标是获得器械上市的监管许可。