HCM-AF ablation with ACUTUS
Research type
Research Study
Full title
Dipole intracardiac mapping with ACUTUS system for catheter ablation of atrial fibrillation in hypertrophic cardiomyopathy
IRAS ID
258033
Contact name
Sabine Ernst
Contact email
Sponsor organisation
Royal Brompton & Harefield NHS Foundation Trust
Duration of Study in the UK
2 years, 0 months, 31 days
Research summary
About 1/4 of patients with hypertrophic cardiomyopathy (HCM) seem to develop atrial fibrillation (AF) over their life-span. Catheter ablation of AF in HCM has been proposed by several centres, but outcomes are much worse than in non-HCM AF with a success rate of ~ 50% with multiple ablation attempts.
The Acutus system provides a simultaneous global chamber live acquisition which uses a noncontact dipole density mapping able to acquire an accurate whole chamber anatomy and density mapping in ~ 20seconds, allowing also calculating a dipole density map derived from the voltage.
The advantage is that it might improve the ablation outcome by identifying more accurately the non-pulmonary veins AF triggers and avoiding additional “unnecessary” RF deliveries possibly responsible for the creation of scars and new triggers for recurrences or new onset of AT post AF-ablation.
This single centre, prospective, double-arm study will include 20 patients with HCM and AF, with already a clinical indication for catheter ablation.
The ablation procedure itself for the first 10 patients (group 1) will be carried out after acquisition of a left and right atrium (LA, RA) dipole map at baseline pre and post administration of Adenosine IV in case baseline HR >80bpm. Then pulmonary vein isolation (PVI) as a first step and subsequent remap and ablation of all patterns of interest in the LA until restoration of SR or decision to proceed with DCCV (360J).
For the second 10 patients (group 2), after the acquisition of a dipole map of LA and RA at baseline (pre and post Adenosine IV administration), ablation of all identified API will be performed, followed by remap and finally PVI +/- DCCV.
For all patients, final step will be the deployment of a RA isthmus line and demonstration of bidirectional block.
Follow up duration will be 12months.
REC name
London - Central Research Ethics Committee
REC reference
19/LO/1548
Date of REC Opinion
3 Oct 2019
REC opinion
Unfavourable Opinion