CLP-AF-006_AcQMap Registry of Procedural Long-term Clinical Outcomes
Research type
Research Study
Full title
AcQMap® Global Registry of Procedural and Long-term Clinical Outcomes.
IRAS ID
258348
Contact name
Simon James
Contact email
Sponsor organisation
Acutus Medical, inc
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 11 months, 18 days
Research summary
Treatment for an irregular heart beat can be with medicines, electrical shocks or re-ablation therapy. The AcQMap High Resolution Imaging and Mapping System uses ultrasound to reconstruct the heart chamber and then overlays high-resolution dipole density maps of electrical activation on the heart surface. The system derives dipole density from sensing of voltage fields emanating from the depolarization of the myocardium and displays that information onto the ultrasound acquired image of the cardiac chamber. The result is an instantaneous, synchronous, and global view that captures the conduction pattern of each activation cycle and enables mapping of both stable and unstable arrhythmias
AcQMap Registry is an observational, prospective, multi-center, multi-national, open-label, registry designed to provide clinical data regarding the commercial, real-life experience with the diagnostic AcQMap System.
Eligible patients for the study must be over the age of 18 and already scheduled for an ablation of an arrhythmia utilizing the diagnostic AcQMap system.
Approximately 500 participants will be enrolled at up to 50 centres worldwide.
The study will last approximately 3 years and participant assessments will occur at: baseline, procedure, 6, 12, 24, and 36 months post-procedure.REC name
East of England - Cambridge South Research Ethics Committee
REC reference
19/EE/0109
Date of REC Opinion
29 Mar 2019
REC opinion
Further Information Favourable Opinion