News | March 13, 2015

First Two Patients Enrolled and Treated in AtriCure’s Landmark Afib Study

Study teams cardiac surgeons and electrophysiologists to perform both surgical and catheter ablation

March 13, 2015 — AtriCure Inc. announced the first two patients in the Dual Epicardial and Endocardial Procedure (DEEP) clinical study have been enrolled and treated at PinnacleHealth CardioVascular Institute in Harrisburg, Pennsylvania. The study is the first of its kind in the United States for the treatment of persistent or longstanding persistent forms of atrial fibrillation (Afib).

In the DEEP study, cardiac surgeons and electrophysiologists work as a team to perform a minimally invasive epicardial (outside the heart) surgical ablation and endocardial (inside the heart) catheter-based ablation. The primary effectiveness endpoint of the study is freedom from Afib and absence of Class I or III antiarrhythmic drug therapy. AtriCure received approval in November 2014 from the U.S. Food and Drug Administration to enroll 220 patients at 25 sites in the DEEP study.

Atrial fibrillation patients who have failed anti-arrhythmic drug therapy and may have received up to two failed catheter ablations are candidates for the DEEP study, which is performed in two phases. In the first phase, the surgeon will make small incisions to perform endoscopic epicardial ablation using the AtriCure Bipolar System, and exclude the left atrial appendage (LAA) with the AtriClip LAA Exclusion System.

The first procedure in the study was performed by Mubashir Mumtaz, M.D., chief of cardiovascular and thoracic surgery at PinnacleHealth.

"We feel privileged to be part of this landmark study in our quest to find a safe and reliable treatment for millions of people affected by atrial fibrillation,” said Mumtaz. “We really believe that this trial will provide much needed insight into this disease. We are excited and feel honored to be able to enroll and treat the first two patients to kick off the trial."

The second phase of the procedure, catheter ablation and endocardial mapping, will be performed by Michael G. Link, M.D., electrophysiologist at PinnacleHealth, about 90 to 120 days after the surgical procedure.

“I am excited about DEEP because the more persistent forms of atrial fibrillation have been historically difficult to treat, with disappointing results,” said Link. “I am honored to be at the forefront of this trial which will hopefully alter the standard of care for these patients."

For more information: www.atricure.com

Related Content

Corindus Announces First Patient Enrolled in PRECISION GRX Registry
News | Robotic Systems| September 18, 2017
September 18, 2017 — Corindus Vascular Robotics Inc.
Two-Year ILLUMENATE Trial Data Demonstrate Efficacy of Stellarex Drug-Coated Balloon
News | Drug-Eluting Balloons| September 18, 2017
Philips announced the two-year results from the ILLUMENATE European randomized clinical trial (EU RCT) demonstrating...
Sentinel Cerebral Protection System Significantly Reduces Stroke and Mortality in TAVR
News | Embolic Protection Devices| September 18, 2017
September 18, 2017 – Claret Medical announced publication of a new study in the...
Fysicon Receives FDA Approval for QMAPP Hemodynamic Monitoring System
Technology | Hemodynamic Monitoring Systems| September 18, 2017
Fysicon announced that it has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its...
Marijuana Associated With Three-Fold Risk of Death From Hypertension
News | Hypertension| September 14, 2017
Marijuana use is associated with a three-fold risk of death from hypertension, according to research published recently...
Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Feature | Cath Lab| September 14, 2017
September 14, 2017 — Here are quick summaries for all the key late-breaking vascular and endovascular clinical trials
Medtronic Announces Japanese Regulatory Approval for In.Pact Admiral Drug-Coated Balloon
News | Drug-Eluting Balloons| September 13, 2017
Medtronic plc announced that the In.Pact Admiral Drug-Coated Balloon (DCB) received approval from the Japanese Ministry...
PQ Bypass Reports Positive Results for Detour System in Patients With Long Femoropopliteal Blockages
News | Peripheral Artery Disease (PAD)| September 13, 2017
A subset analysis of the DETOUR I clinical trial showed promising safety and effectiveness results of PQ Bypass’ Detour...
News | Cardiac Diagnostics| September 12, 2017
Contracting shingles, a reactivation of the chickenpox virus, increases a person’s risk of stroke and heart attack,...
Vascular screening for abdominal aortic aneurysm, peripheral artery disease and hypertension during the VIVA Study in Denmark

Vascular screening for abdominal aortic aneurysm, peripheral artery disease and hypertension during the VIVA Study. Photo credit: Lisbeth Hasager Justesen, Viborg Hospital.

News | Cardiac Diagnostics| September 12, 2017
September 12, 2017 — A new screening program for vascular disease saves one life for every 169 men assessed, accordin
Overlay Init