News | EP Mapping and Imaging Systems | May 02, 2017

Acutus Medical Announces Completion of Enrollment for UNCOVER AF Study

Multi-national study designed to provide clinical evidence regarding the use of the AcQMap System in the treatment of persistent atrial fibrillation

Acutus Medical Announces Completion of Enrollment for UNCOVER AF Study

May 2, 2017 — Acutus Medical recently announced that enrollment has been completed in its pivotal Utilizing Novel Dipole Density Capabilities to Objectively Visualize the Etiology of Rhythms in Atrial Fibrillation (UNCOVER AF) study. The study is evaluating the AcQMap High Resolution Imaging and Mapping System in patients with persistent atrial fibrillation (AF) in Europe and Canada.

The UNCOVER AF clinical study is a prospective, multi-center, multi-national study designed to provide clinical evidence regarding the use of the AcQMap System in the treatment of persistent AF. The trial is being conducted at 13 sites throughout Europe and Canada and has successfully completed enrollment of 129 patients.

The technology reveals the electrical conduction of the whole heart chamber along with the heart wall motion (functional structure). The AcQMap System utilizes the combination of ultrasound to create a computed tomography (CT)-quality anatomy and non-contact, dipole density propagation maps to visualize previously unmappable complex arrhythmias (AF, Atypical Flutter) without the confounding effects of far field signals. This allows physicians for the first time to see real-time electrical activity within the heart chamber, with the ability to remap in seconds to confirm successful substrate modification via ablation therapy.

Acutus received CE Mark approval for AcQMap in May 2016 and is currently pursuing U.S. Food and Drug Administration (FDA) clearance for the system.

Additionally, the company is developing a significantly differentiated ablation technology designed to provide functionality that will further advance and support an electrophysiologist’s desire to produce improved, durable, patient-specific benefits.

For more information: www.acutusmedical.com

Related Content

An screen shot of the Abbott Focal Impulse and Rotor Modulated (FIRM)-guided ablation system used to guide AF ablation procedures.

An screen shot of the Abbott Focal Impulse and Rotor Modulated (FIRM)-guided ablation system used to guide AF ablation procedures. 

News | Atrial Fibrillation | May 14, 2019 | Dave Fornell, Editor
May 14, 2019 – The first prospective, multicenter, randomized, controlled trial to compare conventional pulmonary vei
The Parasym Salustim device ear clip stimulates the vagus nerve, which was found to reduced AF burden compared with a sham procedure in the TREAT AF trial.

The Parasym Salustim device ear clip stimulates the vagus nerve, which was found to reduced AF burden compared with a sham procedure in the TREAT AF trial. 

News | Atrial Fibrillation | May 13, 2019
May 13, 2019 — A randomized clinical trial effectively used nerve stimulation through an ear clip to reduce...
More than 60,000 from the general population in Belgium were screened for AFib using only a smartphone app in the DIGITAL-AF II study. The study used the FibriCheck app found 791 participants has measurements indicative for AF.

More than 60,000 from the general population in Belgium were screened for AFib using only a smartphone app in the DIGITAL-AF II study. The study used the FibriCheck app found 791 participants has measurements indicative for AF.

News | Atrial Fibrillation | May 13, 2019
May 13, 2019 — A digital screening for...
Rivaroxaban is among four new oral anticoagulants (NOAC) now recommended by atrial fibrillation guidelines over the old standard of warfarin.

Rivaroxaban is among four new oral anticoagulants (NOAC) now recommended by atrial fibrillation guidelines over the old standard of warfarin.

 

Feature | Atrial Fibrillation | January 30, 2019
January 30, 2019 — Updated atrial fibrillation (AFib) treatment guidelines released this week now recommend new oral
Aurigen Medical Atrial Fibrillation Device Wins ICI Innovation Award
News | Atrial Fibrillation | December 18, 2018
Irish medical device company AuriGen Medical won the prestigious Global Innovation Award at the International...

An example of the new generation of cardiac monitoring device that is replacing Holter monitoring is the Cardea Solo wearable sensor. The FDA-cleared device automatically analyzes data when the device is turned back into the physician's office and automatically produces a draft summary report. This technology can simplify the workflow by eliminating the need for third-party involvement.

Feature | Atrial Fibrillation | September 13, 2018
Rapid advances in technology to monitor atrial fibrillation (AF or Afib) are enabling clinicians to access real-time
Atrial Fibrillation Patients Diagnosed With Carotid Atery Disease Face Increased Risk of Dementia

Image courtesy of Intermountain Medical Center Heart Institute

News | Atrial Fibrillation | May 24, 2018
Atrial fibrillation patients who are diagnosed with carotid artery disease face higher risks for developing dementia,...
Overlay Init