PARIS, Dec 10, 2020 / PRNewswire / – MicroPort Cardio Rhythm Management (CRM) has announced the first enrollment in the Astral-4LV [1] clinical trial to evaluate the safety and efficiency of Axone ™ , a revolutionary and innovative ventricular lead quadruple left. Axone ™ is designed for use in heart failure patients with indications for cardiac resynchronization therapy (CRT) that require the implantation of a CRT pacemaker (CRT-P) or a CRT implantable defibrillator (CRT-D).
The purpose of this study is to evaluate the chronic safety and performance of the Axone ™ lead for cardiac resynchronization therapy (CRT). CRT requires that a pacing lead be placed in the coronary venous system of the left ventricle (LV). The Axone ™ lead has a diameter of 0.4 millimeters, which is approximately 4 times smaller than the diameter of a standard LV lead, and has been designed to better navigate narrow and tortuous coronary veins.
Axone ™ also features four widely spaced electrodes, which can offer more options for LV pacing sites and allow multipoint pacing with distant electrodes (bizone pacing), for potentially wider resynchronization.
The first implantation of the Axone lead as part of the Astral-4LV study was successfully performed on December 3, 2020, by Professor Frédéric Anselme, Principal Investigator, from the University Hospital of Rouen, France.
“Approximately 30% of patients do not respond to CRT therapy [2] , and one of the main reasons is the difficulty of being able to control the left ventricle in the correct places,” said Professor Frédéric Anselme. “Axone ™ enables finding left ventricular rhythm sites that are inaccessible with standard leads. Axone ™ is what we needed to improve response rate to CRT and have a positive impact on patient outcomes.”
Astral-4LV is a prospective, single-arm, multicenter clinical trial that will enroll 152 patients at 20 centers in France, Germany, Italy, the Netherlands, Portugal , Spain, and Austria .
“We continue to invest in innovative technologies and support clinical trials that provide the strongest possible evidence of safety and efficacy for our therapies,” said Benoît Clinchamps, President of MicroPort CRM. “The Axone ™ cable and Astral-4LV clinical study highlights our commitment to improving the quality of life for patients and saving more lives. We strongly believe that Axone ™ has the potential to be a breakthrough in the treatment of heart failure through resynchronization therapy. “
The primary endpoints are the related complication-free rate and left ventricular rhythm success rate. A secondary endpoint of the Astral-4LV study assesses the success rate of a bizone left ventricular rhythm. The data from the study will be used to support the CE mark of Axone ™. Primary endpoints will be assessed six months after implantation and patients will be followed for four years.
The Axone Project has received funding from the European Union’s Horizon 2020 research and innovation program. MicroPort CRM is leading the project in collaboration with Heraeus GmbH, Germany, Rouen University Hospital, France, and the University of Maastricht, the Netherlands.
About Cardiac Resynchronization Therapy (CRT)
CRT therapy is indicated in patients with heart failure with cardiac desynchronization. CRT devices are implanted under the skin, in the chest area, and are connected to the heart by three transvenous rhythm leads that conduct electrical impulses for the rhythm of the heart. Rhythm leads are placed in the right atrium, right ventricle, and left ventricle. The electrical stimulation of the cardiac chambers that activate its contractions is synchronized in order to restore better pumping efficiency of the heart. CRT therapy has been shown to improve survival and quality of life, and reduce hospitalization in patients with heart failure [3] .
About MicroPort CRM
MicroPort CRM is a pioneer in the field of Heart Rate Management (CRM), whose world headquarters are located in Clamart, near Paris, France. Through our longstanding experience in CRM, MicroPort CRM develops, manufactures and markets cardiac pacemakers, implantable cardiac defibrillators, cardiac resynchronization systems, and ECG diagnostic solutions for the treatment of heart rhythm disorders and heart failure. Our state-of-the-art products are manufactured in Clamart, France, Saluggia, Italy, and in Santo Domingo , Dominican Republic.
For more information, visit: www.microport.com
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2: Auricchio A, Prinzen FW. Non-responders to cardiac resynchronization therapy. Circulation 2011; 75: 521–527. |
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3: Abraham WT, Fisher WG, Smith AL, Delurgio DB, Leon AR, Loh E, Kocovic DZ, Packer M, Clavell AL, Hayes DL, Ellestad M, Trupp RJ, Underwood J, Pickering F, Truex C, McAtee P, Messenger J. Cardiac resynchronization in chronic heart failure. N Engl J Med 2002; 346: 1845–1853. |
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