{"id":3111,"date":"2018-06-04T11:46:32","date_gmt":"2018-06-04T11:46:32","guid":{"rendered":"http:\/\/impulse-dynamics-multisite.flywheelsites.com\/ous\/int\/?post_type=news&amp;p=3111"},"modified":"2018-06-04T11:46:32","modified_gmt":"2018-06-04T11:46:32","slug":"clinical-registry-data-recently-published-fix-hf-5c-presented-late-breaking-clinical-trial-session-ehf-2018","status":"publish","type":"news","link":"https:\/\/impulse-dynamics.com\/global\/news\/clinical-registry-data-recently-published-fix-hf-5c-presented-late-breaking-clinical-trial-session-ehf-2018\/","title":{"rendered":"Clinical Registry Data and recently published FIX-HF-5C were presented at the Late-Breaking Clinical Trial Session at EHF 2018"},"content":{"rendered":"<p>Stuttgart, Germany, May 28th, 2018 \u2013 Impulse Dynamics Germany, GmbH announced results on \u201cReal World\u201d experience from its European Clinical Registry. The results were presented today by Prof. Gerd Hasenfu\u00df, MD, Professor of Internal Medicine and Director of the Heart Center, University Hospital G\u00f6ttingen, Germany at the Late-Breaking Clinical Trials Session of the European Heart Failure Congress in Vienna, Austria.<\/p>\n<div id=\"attachment_3113\" style=\"width: 253px\" class=\"wp-caption alignnone\"><img loading=\"lazy\" decoding=\"async\" aria-describedby=\"caption-attachment-3113\" class=\"wp-image-3113 size-full\" src=\"https:\/\/impulse-dynamics.com\/ous\/int\/wp-content\/uploads\/sites\/2\/sites\/2\/2018\/06\/dr_hasenfuss.png\" alt=\"\" width=\"243\" height=\"333\" \/><p id=\"caption-attachment-3113\" class=\"wp-caption-text\">Prof. G. Hasenfu\u00df, M.D. Director of the Heart Center, University Hospital G\u00f6ttingen, Germany<\/p><\/div>\n<p>CCM\u2122 is a therapy unique to the Optimizer\u00ae family of devices that deliver electrical signals to the heart that are intended to reduce symptoms and improve exercise tolerance in patients with heart failure (HF). 140 of the patients enrolled in the observational registry in Europe had characteristics similar to those of the patients enrolled in the recently finished US FIX-HF-5C study: QRS &lt;130 msec, ejection fraction (EF) between 25% and 45% and NYHA class III or IV HF. Enrollment occurred based on clinical need and all data was independently monitored. The patients in the registry were followed for up to 2 years for hospitalizations, Minnesota Living with Heart Failure Questionnaire (MLWHFQ), and NYHA, and followed up to 3 years for mortality. Reported mortality was compared with that predicted by the Seattle Heart Failure Model (SHFM) and the Meta-Analysis Global Group in Chronic Heart Failure (MAGGIC). A separate analysis was performed on the subgroup of patients with EF between 25-34% and 35-45%.<\/p>\n<p>Highlights of the CCM-Registry results include:<\/p>\n<ul>\n<li>In real-world experience, CCM\u2122 produces results similar to those of previous studies in subjects with LVEF 25-45% and QRS&lt;130ms<\/li>\n<li>Hospitalizations decreased by 75% in the 2-years following CCM\u2122 compared to the 1-year period prior to CCM\u2122<\/li>\n<li>MLWHFQ and NYHA showed significant and progressive improvement over 2-years.<\/li>\n<li>Clinical effectiveness was even greater in patients with EF 35-45%. This subgroup of patients showed a greater benefit in performance improvement and a statistically significant reduction in mortality compared to mortality prediction models<\/li>\n<\/ul>\n<p>\u201cThe results of the Registry and the FIX-HF-5C exceeded my expectations. The \u201cReal World Evidence\u201d of the registry data is consistent with that from the randomized controlled study data from the FIX-HF-5C. The benefits for patients such as improved exercise capacity and quality of life, but also the effects on heart failure morbidity and mortality are impressive and confirm CCM as a valuable treatment option for patients suffering from heart failure\u201d said Prof. Hasenfu\u00df. \u201cIt provides a therapy option for patients with moderately reduced left ventricular systolic function (EF25-45%), who currently have no other options for improvement.\u201d<\/p>\n<p>https:\/\/www.escardio.org\/Congresses-&#038;-Events\/Heart-Failure\/Congress-resources\/cardiac-contractility-modulation-improves-outcome-in-heart-failure-with-reduced?utm_medium=Email&#038;utm_source=HFA&#038;utm_campaign=Heart+Failure+2018+-+Congress+news+day+4+-+29+May<\/p>\n<p>\u201cI would like to thank the Registry Investigators and the Impulse Dynamics&#8217; team for completing this important Registry confirming the Fix-5C randomized study and providing an option for heart failure patients with narrow QRS.\u201d said Dr. Simos Kedikoglou, Impulse Dynamics\u2019 CEO.<\/p>\n<h3>About the Optimizer\u00ae and Cardiac Contractility Modulation Therapy<\/h3>\n<p>CCM\u2122 is the brand name for the nonexcitatory electrical pulses delivered by the implantable Optimizer\u00ae device during the absolute refractory period of the heart cycle to improve systolic contraction of the heart. The Optimizer\u00ae system has been implanted in over 3,500 patients and is currently available in Europe, China, Brazil, India and several other countries around the world. Impulse Dynamics has completed numerous clinical studies, including several randomized controlled trials. The results have been published in over 70 publications in leading medical journals. The Optimizer\u00ae is limited to Investigational use only in the United States.<\/p>\n<h3>About Impulse Dynamics<\/h3>\n<p>Impulse Dynamics is focused on the development of electrical therapies for the treatment of chronic heart failure. As a global leader in cardiac medical innovation, Impulse Dynamics has operations in the United States, Europe, and Asia. For more information please visit <a href=\"https:\/\/impulse-dynamics.com\/ous\">www.impulse-dynamics.com<\/a>.<\/p>\n<p><strong>Impulse Dynamics Germany GmbH<\/strong><br \/>\nBreitwiesenstrasse 19<br \/>\n70565 Stuttgart, Germany<\/p>\n","protected":false},"featured_media":0,"template":"","class_list":["post-3111","news","type-news","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Clinical Registry Data and recently published FIX-HF-5C were presented at the Late-Breaking Clinical Trial Session at EHF 2018 - Global - Impulse Dynamics<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/impulse-dynamics.com\/global\/news\/clinical-registry-data-recently-published-fix-hf-5c-presented-late-breaking-clinical-trial-session-ehf-2018\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Clinical Registry Data and recently published FIX-HF-5C were presented at the Late-Breaking Clinical Trial Session at EHF 2018 - Global - Impulse Dynamics\" \/>\n<meta property=\"og:description\" content=\"Stuttgart, Germany, May 28th, 2018 \u2013 Impulse Dynamics Germany, GmbH announced results on \u201cReal World\u201d experience from its European Clinical Registry. 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