Acutus Medical has completed patient enrolment in the company’s AcQForce Flutter Investigational Device Exemption (IDE) clinical trial.
The trial aims to assess the safety and efficacy of the AcQBlate FORCE sensing ablation catheter and system for treating right atrial typical flutter.
Right atrial flutter is a disorder that generates rapid electrical signals, causing the muscles in the heart’s upper chamber (atria) to contract quickly.
This can lead to an increase in heartbeat and trigger other symptoms, such as chest pain, shortness of breath, dizziness and fainting. Additionally, a continuous rapid heartbeat may increase stress on the heart, thereby increasing stroke risk.
Catheter ablation is a common procedure to treat right atrial flutter disorder.
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The AcQBlate FORCE solution enables physicians to check the amount of contact force being applied to the heart during ablations in real-time.
According to the company, studies have indicated that real-time contact force information facilitates safe and effective therapy, as well as helps to improve patient outcomes.
The trial enrolled a total of 110 patients at 21 sites globally. The final patient follow-up is expected next month.
Acutus Medical interim CEO and chief financial officer David Roman said: “Completing enrolment in the AcQForce Flutter trial represents a significant advancement in our journey to enter the US with a therapeutic technology for the treatment of atrial flutter.
“Acutus has a strong history of partnering with physicians to bring innovative technology to the market to treat atrial arrhythmias, and we are thankful to our clinical trial sites, specifically the dedication and commitment of investigators and their staff, and to our clinical team for their collaboration in reaching this milestone.”
The complete AcQBlate FORCE sensing ablation catheter and system already received full CE Mark in 2020 and is currently available in Europe.