What is cVAD Study?
The catheter-based ventricular assist devices (cVAD) study is a global, IRB-approved, prospective, FDA audited, clinical events committee (CEC)-adjudicated, multi-center study designed to monitor safety and real-world outcomes of patients supported with Impella heart pumps, with a one-year follow-up. The cVAD study, which includes data on more than 5,000 patients, serves as a data repository for FDA post-market and post-approval surveillance of Impella devices. cVAD Study data validates best practices with the goal of improving patient outcomes.
The predecessor to cVAD study, known as USpella registry, was an investigator-initiated registry started in 2009 after the initial 510k clearance of Impella 2.5 by US FDA in 2008. Between 2008 and 2015, a total of 2,873 patients from 59 centers were enrolled in the USpella registry.
1. Vetrovec GW, Anderson M, Schreiber T, et al. The cVAD registry for percutaneous temporary hemodynamic support: A prospective registry of Impella mechanical circulatory support use in high-risk PCI, cardiogenic shock, and decompensated heart failure. Am Heart J 2018; 199:115-21.