RHYTHM AI Receives MHRA Approval to Initiate the ROCSTAR Clinical Trial with STAR MappingTM System
UK Multi-Centre Trial to Recruit 177 Patients in up to 15 Centres
London, UK- 8th October 2020: RHYTHM AI Ltd, a UK company focused on the treatment of Atrial Fibrillation (AF) today announces that it has received approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) to proceed with its multi-centre ‘ROCSTAR’ clinical trial. This program 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 multi-centre 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 multi- centre trial with recruitment starting later this year.
For further information please contact:
RHYTHM AI Ltd: Simon Hubbert, Chief Executive Officer: simon@rhythm-ai.com
* N Engl J Med 2015; 372:1812-1822 DOI: 10.1056/NEJMoa1408288
About Atrial Fibrillation
Atrial Fibrillation (AF) is the commonest abnormal heart rhythm seen in clinical practice in which 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 to 6 million in the USA alone and the prevalence of AF has been projected to increase to 15.9 million by the year 2050, Atrial fibrillation 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 commonest 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%.