Clinical/Multi-Center Trials

Members of the Department of Cardiovascular and Thoracic Surgery serve as co-investigators on a number of national multi-center trials. Representative studies include:

Evaluation of the Heartware Ventricular Assist System for the treatment of advanced heart failure

This study involves implantation of a novel centrifugal pump into end-stage heart failure patients as a bridge to transplantation.

The National Pediatric Heart Transplant Study Group

Involving a group of 21 pediatric heart transplant centers, the study examines outcomes of heart transplantation in the pediatric population.

Outcomes following myocardial revascularization: On and off cardiopulmonary bypass (ROOBY)

The ROOBY study is a multi-center VA cooperative trial with true randomization of equivalent patients into on- or off-pump coronary revascularization. Continued sub-studies are being conducted, following the publication of the primary results in the New England Journal of Medicine.

Specialized program of research excellence (SPORE): Biomarkers for the early detection and chemoprevention of lung cancer

This NIH sponsored program provides translational research between the basic science laboratory of Dr. John Minna with the clinical expertise of the thoracic oncology physicians.

Omega-3 fatty acids for prevention of post-operative atrial fibrillation (OPERA)

This study is intended to determine whether or not the administration of Omega 3 fatty acids may decrease a well-known complication of open heart surgery, which to date has frustrated many clinicians.

NeuRx diaphragm pacing system

Involving a novel diaphragm pacemaker whose electrodes are implanted directly into the diaphragm, this research is intended to provide relief for permanently disabled patients, such as those with high cervical spine injuries and progressively disabled patients with amyotrophic lateral sclerosis (ALS).

Single-dose staphylococcus vaccine

A study to evaluate the efficacy, immunogenicity, and safety of a single dose of staphylococcus aureus vaccine in adult patients scheduled for cardiothoracic surgery is intended to determine whether a vaccine may decrease the chance of the well-known complication of mediastinitis in patients following open heart surgery.

Interagency registry of mechanically-assisted circulatory support (INTERMACS)

INTERMACS is a multi-institutional registry sponsored by the NIH to continually track, report, and improve the results of patients undergoing implantation of ventricular assist devices.

Valiant thoracic stent graft

Evaluation of the Clinical Performance of the Captivia Delivery System for the Endovascular Treatment of Blunt Thoracic Aortic Injuries (RESCUE) involves the clinical evaluation of a novel thoracic stent in the treatment of aortic transections, which permits a minimally invasive approach to an often lethal injury.