What is the 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 the cVAD Study, known as the 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.