CLP-16 AcQForce_AF_EU
Research type
Research Study
Full title
AcQBlate Force Sensing Ablation System EU Study for Atrial Fibrillation (AcQForce AF-EU)
IRAS ID
302784
Contact name
Stephen Murray
Contact email
Sponsor organisation
Acutus Medical
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 5 months, 31 days
Research summary
The AcQForce AF-EU clinical study is a prospective, multi-center, non-randomized global clinical study designed to demonstrate the safety and efficacy of the AcQBlate Force Sensing System. Two distinct, non-randomized cohorts of subjects will be included; a PAF population and a PerAF population who meet all respective inclusion and exclusion criteria and who will be treated with the AcQBlate Force Sensing System. All subjects will undergo catheter ablation of accessible pulmonary veins with the endpoint of creating electrical isolation for each targeted vein. Additional left and right atrial targets identified with substrate mapping and/or conventional electrophysiologic mapping may be ablated, as clinically indicated. The AcQForce AF-EU study is a post-market study that will be run in parallel with a US IDE study of similar design. Data will be combined to support a pre-market approval (PMA) application to the US Food and Drug Administration (FDA).
A follow-up phone call will be completed at 7-days and 1-month to assure compliance with all aspects of the clinical study. Subjects will be followed with clinic visits at 3-, 6-, and 12-months. At established clinic study center visits, subjects will complete a 24-hour continuous ECG recording to assess arrhythmia recurrence. Additionally, a 9 month, 24-hour continuous ECG recording will be completed, however will not require a clinic study center visit.
Weekly and symptom triggered trans-telephonic monitoring (TTM) will be completed throughout the follow-up period. The Atrial Fibrillation Effect on Quality of Life (AFEQT) subject questionnaire and the Medical Outcomes Study Short Form – 12 (SF-12) will be administered to assess for changes in Quality of Life.
Recurrence of atrial arrhythmias during the blanking period (90 + 14-days post index ablation) may be treated with antiarrhythmic drugs (AADs), direct current cardioversion (DCCV), or a single repeat ablation procedure. Interventions performed during the blanking period will not constitute an efficacy endpoint failure.
The safety and efficacy endpoints will be analyzed separately for each cohort.REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
21/NE/0146
Date of REC Opinion
31 Aug 2021
REC opinion
Favourable Opinion