RHYTHM AI Receives MHRA Approval to Initiate the ROCSTAR Clinical Trial with STAR Mapping™ System

UK Multicenter Trial to Recruit 177 Patients in Up to 15 Centers

RHYTHM AI Ltd, a UK company focused on the treatment of atrial fibrillation (AF), announced that it has received approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) to proceed with its multicenter ‘ROCSTAR’ clinical trial. This program will assess the company’s STAR Mapping System as a potential treatment for persistent atrial fibrillation.

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-center 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 antiarrhythmic drugs at an average of 18.5-month follow-up. This compares very favorably to a study which demonstrated that 48% of patients were free from AF at 18-month follow-up without the use of antiarrhythmic drugs using standard 3D mapping technology.(1)

The ROCSTAR multicenter 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 centers and follow the patients to evaluate freedom from AF at 12-month 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 multicenter clinical trial. STAR Mapping has demonstrated a significant improvement in outcomes in a single-center study, and we look forward to evaluating the value of STAR in this UK multicenter trial with recruitment starting later this year.

About Atrial Fibrillation
Atrial fibrillation (AF) is the most common abnormal heart rhythm seen in clinical practice, and occurs when irregular electrical signals wander chaotically throughout the upper chambers (atria) of the heart. AF affects an estimated 1.5 million in the UK and 4-6 million in the U.S., and the prevalence of AF has been projected to increase to 15.9 million by the year 2050. AF is associated with significant clinical morbidity, and is also an independent risk factor for mortality. Thromboembolic stroke is the most serious and debilitating of all the complications of AF, and AF is also known to precipitate and worsen the outcomes of congestive heart failure.

Treatment of AF and its associated complications increases the use of healthcare resources and contributes to the ever-growing costs of healthcare, particularly costs associated with hospitalizations.

Catheter ablation is the most common and most effective treatment for AF, but has limited success in patients in whom the AF is present all the time because of the seemingly random and chaotic nature of the AF. This makes it highly challenging to identify the cause or sources of the AF. This means that even in the best hands, the first-time success rate is usually only around 50%.