ROCSTAR
Research type
Research Study
Full title
Randomised Controlled trial of Stochastic Trajectory Analysis of Ranked signals for catheter ablation of persistent Atrial Fibrillation - Multicentre randomised controlled trial assessing targeted ablation in persistent atrial fibrillation using the Stochastic Trajectory Analysis of Ranked Signals STAR Mapping™ method.
IRAS ID
269264
Contact name
Ross J Hunter
Contact email
Sponsor organisation
Rhythm AI Ltd
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 1 months, 0 days
Research summary
Atrial fibrillation (AF) is the most common heart rhythm abnormality. It affects 1 in 100 people. It can cause unpleasant symptoms of palpitation, shortness of breath and in some can cause heart failure or stroke. AF is triggered by abnormal electrical signals originating both in the pulmonary veins (PV), the veins that drain blood from the lungs into the heart, and in the rest of the left atrium, the heart chamber that the PVs drain into. AF can be successfully treated by a procedure called catheter ablation. This involves passing a wire up the vein at the top of the leg and delivering radiofrequency energy to the atrial tissue. This renders that tissue electrically inert. For many years this procedure has been guided by 3D cardiac mapping systems capable of showing the position of the catheters in the heart. By doing a series of radiofrequency treatments around the mouth of the PVs it is possible to electrically isolate them so that PV signals cannot start or sustain AF. This leaves the left atrial signals untreated and limits the success of the procedure to 50%. To date clinicians have tried numerous ways to identify these remaining left atrial signals, but so far, their efforts have not improved the outcomes of ablation over just isolating the PVs alone (50% success rate). We have developed a technology that can analyse the signals collected during the ablation procedure on the 3D mapping system and show the clinician which signals and sites in the left atria are important for sustaining AF. This STAR mapping™ system allows clinicians, after treating the PVs, to accurately treat the left atrial signals utilizing Star Mapping™ as a guide resulting in improved outcomes (80% success in a recent pilot study). This study aims to test this system in a multicentre randomised controlled trial in the UK.
REC name
London - Dulwich Research Ethics Committee
REC reference
20/LO/0905
Date of REC Opinion
24 Aug 2020
REC opinion
Further Information Favourable Opinion