SURVEILLANCE OF SEX-SPECIFIC UTILIZATION, MORBIDITY, AND MORTALITY FOLLOWING TRANSMYOCARDIAL REVASCULARIZATION The Food and Drug Administration intends to award a contract to the Society of Thoracic Surgeons (STS) for the project entitled "Surveillance of sex-specific utilization, morbidity, and mortality following transmyocardial revascularization (TMR)". This contract shall provide for a study to determine whether the patient selection criteria and results observed following commercial distribution of TMR systems differ from those during the pre-market clinical trials and whether there are gender differences in the utilization, patient selection criteria, and risks of morbidity and mortality associated with TMR. Detailed clinical data shall be collected and analyzed to meet the following specific objectives: 1. characterize the patient population treated with TMR; 2. estimate the operative and 30-day morbity and mortality associated with TMR; 3. identify and quantify the effects of demographic clinical, and procedural factors that are associated with an increased risk of poor clinical outcomes following TMR; 4. determine whether the results of 1-3 are signficantly different than those observed during the pre-market clinical trials; and 5. determine whether the results of 1-3 differ by gender. E-MAIL: Susan Pearlman, Contracting Officer, spearlma@oc.fda.gov. Posted 05/18/00 (W-SN456224).

Loren Data Corp. http://www.ld.com (SYN# 0372 20000522\SP-0002.MSC)