UNCOVER-AF CL-AF-002
Research type
Research Study
Full title
Utilizing Novel dipole density Capabilities to Objectively Visualize the Etiology of Rhythms in Atrial Fibrillation
IRAS ID
208403
Contact name
Andrew Grace
Contact email
Sponsor organisation
Acutus Medical
Duration of Study in the UK
1 years, 6 months, 0 days
Research summary
This is prospective, single-arm, multi-centre, multi-national, non-randomised, post-market study designed to provide clinical data regarding the use of the AcQMap™ System in the ablation (altering of an unwanted electrical pathways in the heart) of persistent atrial fibrillation (AF) (Irregular heart beat).
The Acutus Medical AcQMap System is already approved for use in Europe (post-market). The purpose of this study is to further show the safety and performance of the AcQMap System when used in the treatment of persistent (AF).
The AcQMap™ System is to be used on patients scheduled for an endocardial ablation of
persistent atrial fibrillation (AF). There are several forms of AF and when it is recurrent AF that is sustained for more than seven days it is classified as persistent AF. Current treatment methods for persistent AF include medicines, cardioversion (electrical shock), or ablation.AF is caused by rapid impulses of electricity that derive from the upper chambers of the heart. The AcQMap™ System is an Imaging and Mapping System and is intended for imaging and mapping of cardiac chambers, to map the exact places the impulses come from which will allow the Physician to target the best places ablation sites.
The study will take place at up to fifteen sites in Europe with approximately 125 patients participating. There is a similar study being run in Australia and Canada where the device has not yet been approved. Both studies are being sponsored by Acutus Medical.
The patient population will consist of men and women between 18 – 80 years of age scheduled for an endocardial ablation of persistent AF. Enrolment will take approximately six to eight months. Post-procedure follow up will occur at hospital discharge, 1, 3, 6, and 12 months. Additional heart rhythm recordings will also occur at 9 months. The total study duration is anticipated to be approximately 18 months.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
16/SC/0336
Date of REC Opinion
4 Jul 2016
REC opinion
Favourable Opinion