NCT04463641

Assessment of the Axone Micro Quadripolar Lead for Enhanced Cardiac Resynchronization Therapy

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: MicroPort CRM · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Heart Failure
• Cardiac Resynchronization Therapy

Interventions

Type	Name	Description
DEVICE	Implantation of the Axone 4LV Lead	Implantation of the Axone 4LV Lead

Timeline

• Start date: 2020-12-03
• Primary completion: 2024-06-01
• Completion: 2027-12-01
• First posted: 2020-07-09
• Last updated: 2024-01-05

Locations

21 sites across 7 countries: Austria, France, Germany, Italy, Netherlands, Portugal, Spain