AcQForce Flutter-EU, version 1
Research type
Research Study
Full title
AcQBlate Force Sensing Ablation System EU Study for Atrial Flutter
IRAS ID
292519
Contact name
Simon James
Contact email
Sponsor organisation
Acutus Medical Inc
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 10 months, 31 days
Research summary
Summary of Research
The objective of the study is to confirm the AcQBlate Force Sensing System is safe and effective when used to ablate the cavotricuspid isthmus (CTI) for the treatment of typical atrial flutter when compared to the safety and effectiveness of commercially available historical control catheters.
The Acutus Medical AcQForce Flutter-EU clinical study is a prospective, multi-center, non-randomized global study designed to demonstrate the safety and effectiveness of the AcQBlate Force Sensing Ablation System in the ablation management of cavotricuspid isthmus dependent atrial flutter. The AcQForce Flutter-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 premarket approval (PMA) application to the US Food and Drug Administration (FDA)
All subjects with typical atrial flutter will undergo percutaneous catheter ablation of the cavotricuspid isthmus using the AcQBlate Force Sensing System with the endpoint of achieving bidirectional block (BDB).
Post procedural follow-up visits will be completed at pre-discharge, to assess device and procedure-related serious adverse events (SAEs), a 7-day phone call, and a 30-day clinic visit to assure compliance with all aspects of the study and report on the 30-day Outcome Measure.
Subjects 18 years and older, presenting for a de novo percutaneous cardiac ablation of the cavotricuspid isthmus for typical atrial flutter will be included in the AcQForce Flutter-EU study.
The AcQForce Flutter-EU Study will be conducted at up to 5 clinical study sites in Europe.
The clinical study is anticipated to take approximately 12-months to enroll and will include a 30-day follow-up period. Total clinical study duration is anticipated to be approximately 12-18 months. The per patient clinical study duration is expected to be approximately six (6) weeks.
Summary of Results
A total of twenty-six (26) subjects were evaluated to be in the study and twenty-four (24) consented to be treated by the ablation catheter and system. Of those, twenty (20) subjects were treated (Treated) and four (4) subjects did not qualify and were not treated with the study device (Attempted). Attempted subjects were followed through the 7-Day Follow Up visit for safety events, whereas Treated subjects were followed through the 30-Day Follow up visit for safety and efficacy.
The trial met its primary endpoints for safety and effectiveness. No subjects met the predetermined definition of a safety endpoint event. Therefore, the procedure/device related Serious Adverse Event Free Rate was 100% and the primary safety endpoint was met.
Of the 20 Treated subjects, two subjects (1 in UK and 1 in BE) did not meet the efficacy goal of the study.
The study met the pre-specified performance goals supporting the conclusion that the investigational device is safe and effective when compared to the literature-based control.
There were eight (8) adverse reactions reported in a total of five (5) subjects at two (2) sites. None were considered related to the AcQBlate device or AcQBlate® Force Sensing Ablation System.
The events consisted of the following:
• Atrial tachycardia
• Chronic left ventricular failure
• COVID-19
• Ecchymosis
• Hypertension
• Pericarditis
• Supraventricular extrasystoles
• Temporomandibular joint syndromeREC name
West of Scotland REC 5
REC reference
21/WS/0007
Date of REC Opinion
9 Mar 2021
REC opinion
Further Information Favourable Opinion