Notice Number: NOT- HL-08-122
Release Date: June 30, 2008
Response Date: August 22, 2008
National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov)
This Notice is a time-sensitive Request for Information (RFI) regarding a potential clinical trial of ventricular assist devices (VADs) in NYHA advanced Class III/Early Class IV heart failure patients. This information will be used to assess the interest of the mechanical circulatory support device industry to support a collaborative trial.
This RFI is for planning purposes only and should not be construed as a solicitation for applications or proposals and/or as an obligation in any way on the part of the United States (U.S.) Federal government. The Federal government will not pay for the preparation of any information submitted and/or for the government's use of that information. Information that is provided by a respondent that is confidential commercial or financial information will be maintained in confidence and will not be publicly disclosed unless required by FOIA as determined by the NIH FOIA Office or a court of competent jurisdiction.
The National Heart, Lung, and Blood Institute (NHLBI) convened a working group of experts on heart failure cardiology, cardiac surgery, clinical trial design, medical ethics, and regulatory affairs on March 27-28, 2008, in Crystal City, Virginia, to advise the NHLBI on research directions for the treatment of advanced heart failure through clinical trials using ventricular assist devices (VADs). The executive summary of the working group can be found at http://www.nhlbi.nih.gov/meetings/cu-vad.htm.
The working group considered the highest priority to be a clinical trial to assess the use of VAD therapy in patients who are less ill than those currently eligible for destination therapy.
While many trial details are to be determined, the working group made a number of specific recommendations. These are provided below.
Patient Population Recommendations
Trial Design Recommendations
The importance of testing a strategy of therapy rather than a specific device was emphasized, noting that the field of mechanical circulatory support would best be served by including multiple devices, if feasible. Additionally, the working group recognized that a large majority of the funding for the trial should be provided by industry.
With these recommendations in mind, the NHLBI desires input from the mechanical circulatory support industry to gauge their enthusiasm and interest in collaborating and supporting this potential trial. Responses to this RFI will be used for this purpose.
This RFI invites industry experts and representatives from mechanical circulatory support companies to provide responses to the following questions:
Please submit your responses to VAD-Industry-RFI@nhlbi.nih.gov by August 22, 2008.
Questions about this request for information may be directed to:
J. Timothy Baldwin, Ph.D.
Advanced Technologies & Surgery Branch
Division of Cardiovascular Diseases
National Heart, Lung, and Blood Institute
Two Rockledge Centre, Room 8206
6701 Rockledge Drive
Bethesda, MD 20892-7940
Phone: (301) 435-0513
Fax: (301) 480-1454
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
Office of Extramural
National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
Department of Health
and Human Services (HHS)
Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.