{"id":964,"date":"2018-05-28T07:40:29","date_gmt":"2018-05-28T07:40:29","guid":{"rendered":"http:\/\/impulse-dynamics-multisite.flywheelsites.com\/ous\/?p=964"},"modified":"2024-01-17T04:29:14","modified_gmt":"2024-01-17T09:29:14","slug":"clinical-registry-data-and-recently-published-fix-hf-5c-were-presented-at-the-late-breaking-clinical-trial-session-at-ehf-2018","status":"publish","type":"post","link":"https:\/\/impulse-dynamics.com\/global\/clinical-registry-data-and-recently-published-fix-hf-5c-were-presented-at-the-late-breaking-clinical-trial-session-at-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>[et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;4.0.6&#8243; custom_padding=&#8221;||2px|||&#8221;][et_pb_row column_structure=&#8221;1_3,1_3,1_3&#8243; use_custom_gutter=&#8221;on&#8221; gutter_width=&#8221;1&#8243; _builder_version=&#8221;4.0.4&#8243; background_color=&#8221;#00a1e4&#8243; width=&#8221;100%&#8221; max_width=&#8221;1920px&#8221; min_height=&#8221;462px&#8221; custom_margin=&#8221;-56px|auto||auto|false|false&#8221; custom_padding=&#8221;||0px|||&#8221;][et_pb_column type=&#8221;1_3&#8243; _builder_version=&#8221;4.0.4&#8243;][\/et_pb_column][et_pb_column type=&#8221;1_3&#8243; _builder_version=&#8221;4.0.6&#8243;][et_pb_text _builder_version=&#8221;4.0.6&#8243; header_2_font=&#8221;|300|||||||&#8221; header_2_text_color=&#8221;#ffffff&#8221; header_2_font_size=&#8221;80px&#8221; header_2_letter_spacing=&#8221;5px&#8221; custom_margin=&#8221;78px||||false|false&#8221;]<\/p>\n<h2 style=\"text-align: center;\">NEWS<\/h2>\n<p>[\/et_pb_text][et_pb_divider color=&#8221;#005496&#8243; _builder_version=&#8221;4.0.4&#8243; width=&#8221;53%&#8221; module_alignment=&#8221;center&#8221; custom_margin=&#8221;36px||||false|false&#8221;][\/et_pb_divider][et_pb_text _builder_version=&#8221;4.0.6&#8243; header_font=&#8221;|||on|||||&#8221; header_4_font=&#8221;|||on|||||&#8221; header_4_text_color=&#8221;#FFFFFF&#8221; header_4_font_size=&#8221;30px&#8221;]<\/p>\n<h4 style=\"text-align: center;\">Clinical Registry Data and recently published FIX-HF-5C were presented at the Late-Breaking Clinical Trial Session at EHF 2018<\/h4>\n<p>[\/et_pb_text][et_pb_divider color=&#8221;#005496&#8243; _builder_version=&#8221;4.0.4&#8243; width=&#8221;53%&#8221; module_alignment=&#8221;center&#8221; custom_margin=&#8221;16px||||false|false&#8221;][\/et_pb_divider][\/et_pb_column][et_pb_column type=&#8221;1_3&#8243; _builder_version=&#8221;4.0.4&#8243;][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;4.0.6&#8243; custom_padding=&#8221;0px|||||&#8221;][et_pb_row _builder_version=&#8221;4.0.6&#8243; custom_padding=&#8221;||0px|||&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.0.6&#8243;][et_pb_text _builder_version=&#8221;4.0.6&#8243; header_2_text_color=&#8221;#005496&#8243; custom_margin=&#8221;||7px|||&#8221; custom_padding=&#8221;||0px|||&#8221;]<\/p>\n<p><strong>Stuttgart, Germany, May 28th, 2018<\/strong> \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<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\u2019 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<p>&nbsp;<\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=&#8221;1_3,1_3,1_3&#8243; _builder_version=&#8221;4.0.6&#8243; background_color=&#8221;#005496&#8243; custom_padding=&#8221;37px|36px|37px|36px|true|true&#8221;][et_pb_column type=&#8221;1_3&#8243; _builder_version=&#8221;4.0.6&#8243;][et_pb_text _builder_version=&#8221;4.0.6&#8243; background_layout=&#8221;dark&#8221;]<\/p>\n<p><strong>About the Optimizer and CCM Therapy<br \/> <\/strong>CCM is the brand name for Cardiac Contractility Modulation, the non-excitatory electrical pulses delivered by the implantable Optimizer device during the absolute refractory period of the heart\u2019s cardiac cycle to improve systolic contraction of the heart. The Optimizer System has been implanted in over 4,000 patients and is currently available in the US, Europe, China, Brazil, India, and more than 40 other countries around the world. Impulse Dynamics has completed numerous clinical studies, including several randomized controlled trials, and the results have been published in over 80 articles appearing in leading medical journals.<\/p>\n<p>&nbsp;<\/p>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_3&#8243; _builder_version=&#8221;4.0.6&#8243;][et_pb_text _builder_version=&#8221;4.0.6&#8243; background_layout=&#8221;dark&#8221;]<\/p>\n<p><strong>About Impulse Dynamics<br \/> <\/strong>Impulse Dynamics is a medical device company dedicated to transforming the treatment of chronic heart failure. With global headquarters in Mount Laurel, N.J., the company has additional offices in; Stuttgart, Germany, Orangeburg, N.Y. and Curacao For more information please visit<span>\u00a0<\/span><a href=\"https:\/\/impulse-dynamics.com\/ous\/\">www.impulse-dynamics.com<\/a>.<\/p>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_3&#8243; _builder_version=&#8221;4.0.6&#8243;][et_pb_text _builder_version=&#8221;4.0.6&#8243; background_layout=&#8221;dark&#8221;]<\/p>\n<p><strong>Impulse Dynamics (USA), Inc.<\/strong><br \/> 523 Fellowship Road, Suite 203<br \/> Mt. 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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\/clinical-registry-data-and-recently-published-fix-hf-5c-were-presented-at-the-late-breaking-clinical-trial-session-at-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=\"NEWSClinical Registry Data and recently published FIX-HF-5C were presented at the Late-Breaking Clinical Trial Session at EHF 2018Stuttgart, Germany, May 28th, 2018 \u2013 Impulse Dynamics Germany, GmbH announced results on [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/impulse-dynamics.com\/global\/clinical-registry-data-and-recently-published-fix-hf-5c-were-presented-at-the-late-breaking-clinical-trial-session-at-ehf-2018\/\" \/>\n<meta property=\"og:site_name\" content=\"Global - 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