Heart Failure Clinical Trial
Official title:
Assessment of the Axone Micro Quadripolar Lead for Enhanced Cardiac Resynchronization Therapy
The primary objective of this study is to assess the chronic safety and performance of the Axone left ventricular (LV) micro-lead.
This is a interventional, pivotal, prospective, single arm, open label, multicenter, international trial. The device under investigation is the Axone system, consisting of: - Axone 4LV: an ultrathin, lumenless, quadripolar, IS4-compatible lead designed for left ventricular pacing for cardiac resynchronization therapy (CRT). - Axone µGuide: a dedicated, permanently implantable micro catheter designed for implantation of the Axone 4LV lead. The primary endpoint data will be used to support CE marking of the Axone system. The primary endpoints will be evaluated at 6 months post-implantation. Subjects will be followed-up at 6 weeks, 3 months, 6 months, 12 months post-implantation, then yearly until 4 years post-implantation. ;
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