The AcQForce Flutter trial was designed to assess the safety and efficacy of the company’s AcQBlate FORCE sensor ablation catheter and system in the treatment of right atrial typical flutter
Arrhythmia care company Acutus Medical has completed the patient enrolment in the company’s AcQForce Flutter Investigational Device Exemption (IDE) clinical trial.
The AcQForce Flutter trial was designed to assess the safety and efficacy of the AcQBlate FORCE sensor ablation catheter and system in the treatment of right atrial typical flutter.
Acutus Medical said that the trial enrolled a total of 110 patients at 21 sites around the world.
The AcQBlate FORCE system, which was designed to deliver consistent, effective therapeutic solutions during cardiac ablation operations, displays clinicians how much contact force is being applied to the heart in real-time.
Real-time contact force information has been shown in studies to assist clinicians in guiding safe and effective therapy, potentially improving patient outcomes.
Acutus Medical interim chief executive officer David Roman said: “Completing enrollment in the AcQForce Flutter trial represents a significant advancement in our journey to enter the United States 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 AcQBlate FORCE sensing ablation catheter and system, which obtained full CE Mark in late 2020, is now available for sale in Europe.
The AcQBlate FORCE sensing ablation catheter and system will be submitted for Pre-Market Approval (PMA) in the third quarter of this year, with a final patient follow-up expected in June 2022.
In May last year, the arrhythmia management company secured an investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to begin atrial fibrillation (AF) clinical study with the AcQBlate Force sensing ablation catheter and system.