UK MHRA Gives Greenlight for ‘ROCSTAR’ Multicenter Study Testing Prospective Treatment for Persistent Atrial Fibrillation

UK MHRA Gives Greenlight for ‘ROCSTAR’ Multicenter Study Testing Prospective Treatment for Persistent Atrial Fibrillation

Rhythm AI recently notified the market that their multicenter ‘ROCSTAR’ clinical trial was given the green light by the UK Medicines and Healthcare Products Regulatory Agency (MHRA). Now the company’s STAR Mapping System will be investigated as a prospective treatment for persistent atrial fibrillation (AF).

Background

Atrial fibrillation (AF) is the most common arrhythmia with an expected rise in prevalence over the next decade. AF, in addition to behind problematic symptoms, is associated with increased mortality and morbidity. Catheter ablation is a safe treatment effective for paroxysmal AF, but persistent AF’s success rate remains about 50% in one year.

Hence the introduction of the new mapping technique known as Stochastic Trajectory Analysis of Ranked signals (STAR Mapping™). 

Pilot Study

In a pilot study, localized sources driving AF were consistently mapped and ablated with excellent acute and long term outcomes. The outcomes in the single-center trial were published in May 2019. The study team found that 80% of patients treated in a single procedure using the investigational method were free of AF without the use of anti-arrhythmia treatments with a mean of 18.5 months follow up, reported Cardiac Rhythm News. This study compared well to another, which revealed 48% of patients free from AF at 18 months follow-up without antiarrhythmic drugs involved with standard 3D mapping technology, commented Cardiac Rhythm News

The Study

This study will investigate the clinical effectiveness of this approach (in the pilot) by comparing conventional ablation with pulmonary vein isolation (PVI) to PVI plus STAR Mapping™ guided ablation. The study team will investigate this through the prospective multicenter randomized controlled trial involving 177 patients.

Involving 15 centers, the “real world” study in partnership with Biosense Webster, a Johnson & Johnson company.

The Sponsor

Rhythm AI Ltd. is developing a new approach to locating areas within the heart responsible for the most common heart rhythm disorder—atrial fibrillation (AF). The company’s proprietary STAR Mapping software helps guide doctors during ablation procedures and will help them make sense of the large quantities of data gathered. Following highly promising results from proof-of-concept testing, Rhythm now moves on to its multicenter clinical trial. According to Crunchbase, the company has raised 2.2 million pounds.