RELEASE DATE:  May 13, 2004
NOTICE:  NOT-HL-04-112

National Heart, Lung, and Blood Institute (NHLBI)

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 

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 

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: 
and posted at:  Proposals will be due to be received on 
August 4, 2004.  This announcement does not commit the Government to award a 

Contracting Office Address:

National Institutes of Health
National Heart, Lung, and Blood Institute
Contracts Operations Branch
Rockledge Building (RKL2), Room 6224
BETHESDA, MD 20892 -7902

Point of Contact:

Douglas Frye, Contracting Officer, Phone 301-435-0330, Email

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