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.
The primary objective of this study is to assess the chronic safety and performance of the Axone left ventricular (LV) micro-lead.