Towards virtual laboratory for optimizing cardiac rhythm

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.RELEVANCE TO PUBLIC HEALTH Each year 210k people in the US alone survive their first heart attack, and over half of these survivors will develop ventricular tachycardia (VT), a life-threatening heart rhythm, within their lifetime. The survivors that live with VT have a poor quality of life and high mortality. CardioSolv Ablation Technologies Inc. is has developed a patient-specific simulation-guided methodology for guiding doctors to place precise ablation lesions in the heart that eliminate VT, leading to dramatic improvements in outcomes, longevity, and quality of life for patients while reducing costs and improving access to care. The proposed work will move this technology to the cusp of regulatory clearance to market, within reach of finally delivering the promised benefits to patients.