Rhythm AI has today announced that it has received approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) to proceed with its multicentre ‘ROCSTAR’ clinical trial. This programme will assess the company’s STAR Mapping System as a potential treatment for persistent atrial fibrillation (AF).
STAR Mapping is a new, AI-driven mapping system developed using novel computer algorithms to identify the sources or drivers of AF from data acquired from 3D Mapping equipment. Outcomes in a single-centre study published in May 2019 demonstrated that 80% of patients treated in a single procedure using STAR Mapping were free of AF without the use of anti-arrhythmia drugs at an average of 18.5 months follow-up. This compares very favourably to a study, which demonstrated 48% of patients free from AF at 18 months follow-up without the use of anti-arrhythmic drugs using standard 3D mapping technology.
The ROCSTAR multicentre clinical trial is designed to be a ‘real-world’ evaluation of the STAR Mapping System as a potential treatment for patients undergoing cardiac ablation procedure for the treatment of persistent AF. The trial will recruit 177 patients in up to 15 UK centres and follow the patients to evaluate freedom from AF at 12 months follow-up.
Simon Hubbert, chief executive officer of RHYTHM AI said: “We are very pleased to have received approval from the MHRA to start the ROCSTAR multicentre clinical trial. STAR Mapping has demonstrated a significant improvement in outcomes in a single-centre study and we look forward to evaluating the value of STAR in this UK multicentre trial with recruitment starting later this year.”