Sponsor Name

Shenzen Medical Technology

Brief summary

LVAD Corheart6 is a single arm, prospective, open label and multicenter pre-market study. The objective is to to evaluate the safety and effectiveness of the Corheart 6 VAS when used for the treatment of advanced, refractory heart failure in an European population. The objective is to enroll 50 patients at 10 investigational sites and patients will be followed up to 5 years after procedure.

Primary endpoints

It is a composite of survival to transplant, recovery or 6 months of support (whichever occurs first), free of disabling stroke (modified Rankin Score > 3) or re-operation to replace the original pump.

CERC Services

Site selection

Regulatory submission

 Project management

Contract management

Site monitoring

SAE reporting

CEC activities

DSMB activities

Data management

Statistical Analysis

Countries

Around 2 countries across Germany and Austria.

Number of investigational sites: 10