Cardiovascular Devices Unit Research Track

Circulatory and cardiovascular devices are one of the fastest moving, highest impact areas of medical therapeutics. Blending regulatory, academic and industry priorities into optimal clinical trial designs provides challenging opportunities for creativity and teamwork.

 

The DCRI Cardiovascular Devices Unit is a dedicated cross-section of clinical and statistical faculty and operational staff focused on the design, execution and reporting of national and global clinical trials testing novel cardiovascular devices. Our activities involve pre- and post-market new device assessment from strategic planning, protocol development and statistical analysis plan through site selection, study initiation and data analysis and reporting. New percutaneous drug eluting stents, distal protection systems, thrombectomy, atherectomy, photodynamic therapy, septal occluders and valves represent unique therapeutic areas of application. In addition to these therapeutic devices, invasive and implantable diagnostic devices detecting vulnerable plaque or continuously monitoring intracardiac pressures represent unique clinical trial opportunities and challenges.

 

Cardiovascular medicine fellows involved in the unit's research receive training and participate in trial design development, learn regulatory process and requirements, statistical principles and work directly with at least one entrepreneurial study sponsor.