RHYTHM AI announces publication of successful STAR Mapping™ clinical outcome trial that identified Atrial Fibrillation (AF) drivers in all study patients

Mapping Image

STAR Mapping guided ablation of Atrial Fibrillation (AF) drivers led to either AF termination or Cycle Length slowing in all patients

Prospectively designed study used conventional mapping catheters

London, 17 November 2020:  RHYTHM AI Ltd, a UK company focused on the treatment of Atrial Fibrillation (AF), today announces publication of a human clinical outcome study for its STAR (Stochastic Trajectory Analysis of Ranked signals) Mapping™ system designed to improve outcomes in patients receiving ablation treatment for persistent AF. The article in the peer-reviewed journal, Circulation: Arrhythmia and Electrophysiology is entitled; “Prospective STAR-Guided Ablation in Persistent Atrial Fibrillation Using Sequential Mapping With Multipolar Catheters”.*

STAR Mapping uses novel computer algorithms to identify the sources or drivers of AF from data acquired from the standard procedure equipment. This study is the first STAR Mapping study to be conducted using sequential mapping catheters. Importantly these are the standard catheters used in an AF ablation procedure and does not necessitate the use of additional medical devices.

Key highlights from the study:

  • 30 patients with persistent AF were included in the trial
  • Three patients 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.
  • A positive response (AF termination or Cycle Lengths slowing of ≥30ms) was achieved with STAR Mapping guided ablation in all 27 patients
  • 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 drug

Simon Hubbert, Executive Chairman of RHYTHM AI said: “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.”

* Honarbakhsh S, Schilling RJ, et al; Circ Arrhythm Electrophysiol, 2020 Oct;13(10): e008824. doi: 10.1161/CIRCEP.120.008824. Epub 2020 Sep 9. Full paper available at https://pubmed.ncbi.nlm.nih.gov/32903033/

READ FULL PAPER

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.

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 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%.