Clinical Trials

Clinical Trials

The state-of-the-art surgical facility at the Cardiovascular Innovation Institute (CII) is the only facility in the region devoted to large animal cardiovascular research. Few laboratories are capable of conducting these types of clinical trials on a large scale with regard to the number of procedures completed and the Good Laboratory Practices (GLP) capabilities that are required prior to FDA approval of devices.

Animal clinical trials are essential, as cardiac devices cannot be downsized and must be tested in an animal model with cardiovascular anatomy and physiology similar to humans. The Animal Care and Use Program at the University of Louisville has been fully accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) since 1965. The facilities and animal care program are maintained to comply with the USDA Animal Welfare Act and Regulations and the Guide for the Care and Use of Laboratory Animals.

All animal research activities performed in the CII have prior approval by the UofL Institutional Animal Care and Use Committee, which is comprised of researchers, veterinarians and non-scientific and community members. The veterinary staff participates in collaborative research projects with CII investigators. This unique relationship between the CII and UofL Research Resources Facility provides for an ideal environment for the development of cardiovascular devices and procedures that could transform clinical care for cardiac patients.

For more information, please visit http://www.cv2i.org..