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

Patients with atrial fibrillation are at far greater risk of a catastrophic COVID outcomes, so steps should be taken to reduce AFib risks in addition to precautions against COVID like making, hand washing and social distancing. Images include an electromap from an AF ablation procedure and a COVID-19 from the CDC. 

Patients with atrial fibrillation are at far greater risk of a catastrophic COVID outcomes, so steps should be taken to reduce AFib risks in addition to precautions against COVID like making, hand washing and social distancing. Images include an electromap from an AF ablation procedure and a COVID-19 from the CDC. 

Feature | Atrial Fibrillation | January 27, 2021 | By John D. Day, M.D., T. Jared Bunch, M.D., and Matthew D. LaPlante
In our most challenging and distressing days, it is nice to think about a post-COVID-19 world. 
ECG with paroxysm correct form of atrial flutter. Getty Images

ECG with paroxysm correct form of atrial flutter. Getty Images

News | Atrial Fibrillation | December 23, 2020
December 23, 2020 — The American College of Cardiology (ACC) and the American Heart Association (AHA) has made two up
The three-year clinical outcomes of the mHealth Screening to Prevent Strokes (mSToPS) study evaluated the detection of silent, or previously undiagnosed, atrial fibrillation (AF) in moderate-risk individuals using the FDA-cleared Zio by iRhythm ambulatory monitoring patch. The results support the clinical value of early screening and targeted detection in moderate-risk populations. #AHA #AHA20 #AHA2020

The three-year clinical outcomes of the mHealth Screening to Prevent Strokes (mSToPS) study evaluated the detection of silent, or previously undiagnosed, atrial fibrillation (AF) in moderate-risk individuals using the FDA-cleared Zio by iRhythm ambulatory monitoring patch. The results support the clinical value of early screening and targeted detection in moderate-risk populations.

News | Atrial Fibrillation | November 16, 2020
November 16, 2020 — The three-year clinical outcomes of the mHealth Screening to Prevent Strokes (mSToPS) study evalu
The Medtronic SEEQ mobile cardiac telemetry system, pictured here, and the Icentia CardioSTAT cardiac rhythm monitoring device both found in reased rates of post-operative atrial fibrillation in the SEARCH-AF trial presented at the American Heart Association annual meeting. #AHA #AHA20 #AHA2020

The Medtronic SEEQ mobile cardiac telemetry system, pictured here, and the Icentia CardioSTAT cardiac rhythm monitoring device both found in reased rates of post-operative atrial fibrillation in the SEARCH-AF trial presented at the American Heart Association annual meeting.

News | Atrial Fibrillation | November 16, 2020
November 16, 2020 — Atrial fibrill...
The Medtronic Arctic Front cryoballoon balloon was used a a front-line treatment of AF in the EARLY-AF trial. It was found to be better than anti-arrhythmic drugs in preventing the recurrence of abnormal heart rhythm (atrial tachyarrhythmia, atrial fibrillation), and improve patient well-being.  #AHA #AHA2020 #AHA20

The Medtronic Arctic Front cryoballoon balloon was used a a front-line treatment of AF in the EARLY-AF trial. It was found to be better than anti-arrhythmic drugs in preventing the recurrence of abnormal heart rhythm (atrial tachyarrhythmia, atrial fibrillation), and improve patient well-being.  

News | Atrial Fibrillation | November 16, 2020
November 16, 2020 – Doctors from the Mo...

The study used cadaver hearts that were images with contrast enhanced MRI and the images used to create a 3-D computation model of the electrical activation in the heart and how it was influenced by adenosine and ablation. Find more images in the original article

News | Atrial Fibrillation | October 08, 2020
October 8, 2020 – People who suffer from persistent atrial fibrillation in the heart may find relief from a new treat
The TactiFlex PAF investigational device exemption (IDE) study will evaluate he investigational TactiFlex Ablation Catheter, Sensor Enabled (SE) to treat people suffering from paroxysmal atrial fibrillation (PAF). 

The TactiFlex PAF investigational device exemption (IDE) study will evaluate he investigational TactiFlex Ablation Catheter, Sensor Enabled (SE) to treat people suffering from paroxysmal atrial fibrillation (PAF). 

News | Atrial Fibrillation | August 04, 2020
August 4, 2020 — Abbott announced the first enrollments in the TactiFlex PAF  investigational device exemption (IDE)