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 [email protected]

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