COPEC study
Research type
Research Study
Full title
Randomised Comparison of the Octaray™ and PEntaray™ Catheters.
IRAS ID
320863
Contact name
Waqas Ullah
Contact email
Sponsor organisation
University Hospital Southampton NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 11 months, 30 days
Research summary
Atrial fibrillation (AF) is a common heart rhythm disturbance, which if left untreated can lead to significant mortality and risk of stroke. It can be treated with a procedure using a catheter, ablating (using radiofrequency energy i.e. heat) to cause scar tissue that interrupts the abnormal heart rhythm. Standard care involves using a Pentaray™ mapping catheter during the procedure to map the geometry of the Left Atrium (LA-top chamber on left hand side of heart) prior to any ablating to better determine the area responsible for causing the rhythm disturbance.
A newer version of this catheter has recently become available. Octaray™ Mapping catheter has 8 spokes, instead of 5 (Pentaray™) and in preclinical studies Octaray™ has provided maps faster, at higher density and with greater accuracy at identifying areas to ablate. Both catheters are CE marked and being used within their Instructions for Use.
This study is comparing LA maps from both catheters by recruiting 30 participants from one site, Southampton General Hospital. All of whom are clinically indicated for a LA ablation for AF. At the beginning of the procedure the participant will be randomly allocated to have an LA map collected with one catheter then the other, prior to any ablation occurring. The first map will be hidden from the clinician whilst mapping the second time. Data recorded will include time to collect LA geometry, density, comparison of low voltage areas and procedure complication rates.
The participant will be in the study for one day only, unless any untoward medical event occurs. This will result in a 30 day notes review and any SAE will require an independent Cardiologist review, as well as completing all usual reporting requirements.REC name
London - Stanmore Research Ethics Committee
REC reference
23/LO/0840
Date of REC Opinion
9 Nov 2023
REC opinion
Further Information Favourable Opinion