MARLBOROUGH, Mass., June 29, 2017 /PRNewswire/ -- CardioFocus, Inc., a medical device innovator and manufacturer dedicated to advancing ablation treatment for cardiac disorders such as atrial fibrillation (AF), today announced that its HeartLight Endoscopic Ablation System is being featured in three new major clinical studies currently underway. Collectively, up to 1,000 AF patients will be enrolled in these studies.

• The first study, titled, "CardioFocus vs. Contact Force Guided Pulmonary Vein Isolation in Paroxysmal Atrial Fibrillation (CF²)," is a prospective, multi-center, randomized study comparing the acute procedure and safety outcomes as well as long-term clinical outcomes of two groups of patients. One group is being treated with the HeartLight System and the other with a commercially available Contact Force Sensing Irrigated Radiofrequency (RF) ablation catheter plus, at the operator's discretion, 3D Electroanatomical Mapping (EAM) for the treatment of paroxysmal AF. The study will recruit up to 350 patients at approximately 10 centers throughout Europe. Dr. Andreas Metzner from Asklepios Klinik St. Georg in Hamburg, Germany is leading the study.



• A second randomized study, led by the Cardiovascular Center Bethanien (CCB) in Frankfurt am Main, Germany, will enroll a total of 400 patients in Europe. 100 patients with paroxysmal AF will be treated with the HeartLight System and 100 paroxysmal AF patients will be treated with the Cryoballoon. Additionally, 100 persistent AF patients will be treated with the HeartLight System and 100 persistent AF patients will be treated with the Cryoballoon. Comparisons across these groups will be analyzed. Drs. Boris Schmidt and Julian Chun, from CCB are the principal investigators for this study. Both previously authored a paper comparing the performance of the HeartLight System to ablation with the Cryoballoon in the paroxysmal AF population. That study showed a 73 percent success rate (freedom from AF) at 12 months with the HeartLight System as compared with 63 percent with the Cryoballoon.



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• The third study, titled, "The Post-Approval Study (PAS) of the HeartLight Endoscopic Ablation System for the Treatment of Atrial Fibrillation," is evaluating the clinical outcomes of a cohort of patients treated during commercial use of the HeartLight System to confirm results of the successful U.S. clinical pivotal study and study additional research questions. The study will include up to 250 enrolled patients and up to 25 sites in the U.S.

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