ANNOUNCEMENT OF AVAILABILITY: INTERAGENCY REGISTRY OF MECHANICAL CIRCULATORY SUPPORT FOR END-STAGE HEART FAILURE RFP-NHLBI-HV-05-08 RELEASE DATE: May 13, 2004 NOTICE: NOT-HL-04-112 National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov/) The goal of the proposed program is to establish a data and clinical coordinating center (DCC) to manage a registry of patients receiving a mechanical circulatory support device (MCSD) to treat heart failure. The registry will collect and analyze clinical and laboratory data and tissue samples from patients who are receiving MCSDs as destination therapy for end-stage heart failure at 60 to 70 participating hospitals. It is anticipated that the registry will collect data, blood and tissue samples from approximately 2,000 new patients per year for a period of five years. The program will be performed in two phases. In Phase I (6 months), the DCC will develop a protocol, manual of operations, study forms and formats for web-based collection, and methods to insure accuracy of data submitted to the registry. The manual of operations will include policies for publication, conflict of interest, privacy issues, data security and use of stored data. During this phase, criteria to certify hospitals to participate in the program will be established and training plans will be developed for registry personnel. In Phase II (4 years and 6 months), the DCC will provide overall coordination of the program. Participating hospitals will be trained, certified and required to maintain established performance standards. Eligible patients will be consented, enrolled and their data and samples collected. The DCC will monitor study progress and assure data accuracy. Each participating hospital will be site visited during this phase and additional site visits may be performed as needed. Also, during this phase, the DCC will consider revision to the protocol and manual of operations as appropriate in response to new devices or changes in knowledge and treatment of heart failure patients. In performing the work of the registry, the DCC will work closely with the following committees: o Steering Committee - This committee will define enrollment, establish eligibility for detailed follow-up, determine a target number of patients for each device, finalize the protocol and provide scientific direction to the registry at an operational level. The Steering Committee will consist of the Principal Investigator of the DCC, the Steering Committee Chairperson, staff members from the Food and Drug Administration (FDA) and Centers for Medicare and Medicaid Services (CMS), and representatives from the selected participating hospitals. o Operations Committee - This is an executive committee of the Steering Committee with oversight and authority for the day to day operations of the study. The Operations Committee will include the Principal Investigator of the DCC, the Steering Committee Chairperson, and representatives from the FDA and CMS. o Data and Safety Monitoring Board (DSMB) - This Board will be appointed by the NHLBI and will be established to monitor overall progress, data outcomes and patient safety. The DSMB will periodically evaluate procedures, findings, and adverse events and advise the NHLBI when changes should be made. This announcement is not a request for proposals (RFP). It is anticipated that RFP-NHLBI-HV-05-08 for this program will be available on or about May 19, 2004 through the NHLBI Website at: http://www.nhlbi.nih.gov/funding/inits/index.htm#rfp and posted at: http://www.fedbizopps.gov. Proposals will be due to be received on August 4, 2004. This announcement does not commit the Government to award a contract. Contracting Office Address: National Institutes of Health National Heart, Lung, and Blood Institute Contracts Operations Branch Rockledge Building (RKL2), Room 6224 6701 ROCKLEDGE DR, MSC-7902 BETHESDA, MD 20892 -7902 Point of Contact: Douglas Frye, Contracting Officer, Phone 301-435-0330, Email df23a@nih.gov
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