Rhythm AI has announced publication of a human clinical outcome study for its Stochastic Trajectory Analysis of Ranked signals (STAR) mapping system in Circulation: Arrhythmia and Electrophysiology. STAR mapping is designed to improve outcomes in patients receiving ablation treatment for persistent atrial fibrillation (AF).
STAR Mapping uses computer algorithms to identify the sources or drivers of AF from data acquired from the standard procedure equipment. The study is the first STAR Mapping study to be conducted using sequential mapping catheters. These are the standard catheters used in an AF ablation procedure and does not necessitate the use of additional medical devices.
Thirty patients with persistent AF were included in the trial, with three patients of these patients having had AF terminated during the pulmonary vein isolation (PVI) procedure. Commercially available multipolar catheters and equipment were used to gather sequential data for STAR Mapping in the remaining 27 patients, AF drivers were identified in 100% of patients using STAR Mapping.
The study found that a positive response (AF termination or cycle lengths slowing of ≥30ms) was achieved with STAR mapping guided ablation in all 27 patients. Additionally, 81.5% of patients (22 of 27) undergoing STAR guided ablation were free from AF at an average follow up time of 17.3 months without the need for antiarrhythmic drugs
Simon Hubbert, chief executive of RHYTHM AI Ltd, commented: “We are delighted with the results from this study which further strengthens our belief that STAR Mapping may significantly improve outcomes for patients undergoing ablation treatment for persistent AF. In September, MHRA approved our application to evaluate STAR Mapping in the ROCSTAR multi-centre randomised trial and we look forward to announcing results from this trial in the future.”