MicroPort Cardio Rhythm Management (CRM) announced the first recruitment for the Astral-4LV clinical trial to evaluate the safety and efficacy of Axone, a left ventricular lead innovative and revolutionary quadrupole. Axone is designed for use in patients with heart failure with indications for cardiac resynchronization therapy (CRT / CRT) that require the implantation of a CRT pacemaker (CRT-P) or implantable defibrillator CRT (CRT-D).
The objective of this study is to assess the chronic safety and performance of the leader Axone for cardiac resynchronization therapy (CRT / CRT). CRT requires that a pacing lead be placed in the coronary venous system of the left ventricle (LV). The Axone lead is 0.4mm in diameter, approximately four times smaller than the diameter of a standard LV lead, and has been designed to better navigate narrow, tortuous coronary veins.
Axone also has four widely spaced electrodes, which can provide more options for LV stimulation sites and allow multipoint stimulation with distant electrodes (dual-zone stimulation), for potentially wider resynchronization.
Frédéric Anselme, Professor, Center Hospitalier Universitaire de Rouen, France said: “About 30% of patients do not respond to CRT therapy, and one of the main reasons is the difficulty of being able to stimulate the left ventricle in the right places. Axone helps find left ventricular pacing sites that are inaccessible with standard leads. Axone is what we needed to improve the response rate to CRT and positively impact patient outcomes.”
Benoît Clinchamps, President, MicroPort CRM said: “We continue to invest in innovative technologies and support clinical trials that provide the strongest possible evidence for the safety and efficacy of our therapies. The Axone probe and the Astral-4LV clinical study underscore our commitment to improving patient quality of life and saving more lives. We strongly believe that Axone has the potential to be a breakthrough in the treatment of heart failure with resynchronization therapy.”