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.
Sponsors
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 qualification
- Regulatory submissions
- Sites Contracts & Fees management
- Project management
- Electronic Data Capture Management
- Site and Monitoring Management
- CRF and Data management
- CEC and DSMB activities
- Safety reporting
- Statistical Activities
- Clinical report
Countries
Germany
Austria
Number of investigational sites
10
