News | February 24, 2012

First Patient Treated in CardioFocus HeartLight AF Ablation System Pivotal Trial

February 24, 2012 — CardioFocus Inc., developer of the HeartLight Endoscopic Ablation System (EAS) for the treatment of atrial fibrillation (AF), announced the first patient has been enrolled and treated in the HeartLight EAS U.S. pivotal trial, designed to evaluate the safety and efficacy of the technology in treating symptomatic AF.

The 48-year-old patient, one of nearly three million Americans with AF, had suffered from paroxysmal AF for three years and underwent successful pulmonary vein (PV) isolation at Mount Sinai School of Medicine in New York. All four PVs were isolated on the very first attempt using only visual guidance during the approximately two-hour procedure.

The HeartLight EAS is the first catheter ablation system to incorporate an endoscope for direct visualization of a beating heart, in real time and without radiation. It includes a compliant, dynamically adjustable balloon catheter designed for improved contact with the PV ostium irrespective of individual patient anatomy, and utilizes laser energy for more efficient, durable and precise ablation. The U.S. Food and Drug Administration (FDA) granted investigational device exemption (IDE) approval for HeartLight EAS in December 2011, enabling the initiation of the trial.

“The visually-guided HeartLight EAS is unique in cardiac catheter ablation and offers a promising new treatment option for drug-refractory AF. For the first time, physicians can see within a beating heart to more precisely deliver ablation energy and confirm contiguous lesion placement, which we believe may lead to improved patient outcomes,” said Vivek Y. Reddy, M.D., of Mount Sinai School of Medicine, and principal investigator of the trial. “The system has been used with great clinical success in Europe, with recent published data supporting the high rate of both acute and durable PV isolation enabled by the device. We are optimistic that we will be able to achieve similar results in this trial.”

The prospective trial will randomize the HeartLight EAS against the NaviStar ThermoCool Catheter (Biosense Webster). Only a single ablation procedure with the HeartLight EAS will be permitted, while repeat ablation may be performed with the ThermoCool system. In total, the trial will randomize an estimated 350 patients at up to 25 sites in the United States and follow them for one year post-procedure.

The primary outcome measures will assess both safety and freedom from documented, symptomatic AF. The results will be used as the basis for CardioFocus’s premarket approval (PMA) filing with the FDA for HeartLight EAS. In addition to Mount Sinai, Texas Cardiac Arrhythmia Research Foundation in Austin, Texas, is also currently enrolling patients.

For more information:

Related Content

Smartphone Apps Help Patients and Providers Manage Atrial Fibrillation
News | Patient Engagement| October 19, 2017
October 19, 2017 — Novel smartphone and tablet applications for atrial fibrillation patients and healthcare professio
Pregnancy-Related Heart Failure Strikes Black Women Twice as Often as Other Races
News | Womens Healthcare| October 19, 2017
African American women were found to be twice as likely to be diagnosed with peripartum cardiomyopathy as compared to...
The Respicardia Remede System is a pacemaker-like device designed to improve cardiovascular health by restoring natural breathing during sleep in patients with Central sleep apnea.
Technology | Heart Failure| October 18, 2017
October 18, 2017 — The U.S.
MRI May Predict Neurological Outcomes for Cardiac Arrest Survivors
News | Sudden Cardiac Arrest| October 18, 2017
Magnetic resonance imaging (MRI)-based measurements of the functional connections in the brain can help predict long-...
Xarelto Significantly Reduces Major Cardioavascular Events in Stable CAD and PAD Patients
News | Pharmaceuticals| October 18, 2017
October 18, 2017 — Results from the pivotal Phase 3 COMPASS study found that the...
Baylis Medical and Siemens Co-Sponsor Transseptal Access Training Course
News | EP Lab| October 18, 2017
Baylis Medical Co. Inc. and Siemens Healthineers are co-sponsoring a first-of-its kind training program aimed at...
First Patient Enrolled in U.S. Arm of ALIVE Pivotal Heart Failure Trial
News | Heart Failure| October 17, 2017
October 17, 2017 — BioVentrix Inc. recently announced enrollment of the first patient in the U.S.
Low Mortality and Stroke Risks Displayed for Minimally Invasive Aortic Valve Replacements
News | Heart Valve Technology| October 11, 2017
An analysis of more than 1,000 minimally invasive aortic valve replacements and more than 400 additional associated...
CardioFocus Announces European CE Mark Approval of HeartLight Excalibur Balloon
Technology | Ablation Systems| October 10, 2017
October 10, 2017 — CardioFocus Inc. recently announced the European CE Mark approval of the HeartLight Excalibur Ball
New Evaluation Sends Low-Risk ER Chest Pain Patients Home Sooner
News | Cardiac Diagnostics| October 10, 2017
A new evaluation to determine whether emergency room patients with chest pain can go home and follow up with their...
Overlay Init