The ASTRAL-4LV study (Assessment of a micro quadripolar lead for enhanced cardiac resynchronization therapy) is an interventional, pivotal, prospective, single arm, open label, multicenter, international clinical trial.

The primary objective of this study is to assess the chronic safety and performance of Axone, to support the product’s regulatory approval. 152 subjects are to be implanted in 20 different centers across Europe, with a follow-up at 6 weeks, 3 months, 6 months, 12 months post-implantation, then yearly until 4 years post-implantation.

More information regarding the ASTRAL-4LV study can be found in the Clinicaltrials.gov database, with the identifier NCT04463641.