MODIFICATION
R -- LAMPOON Protocol IDE Enrollment Sites
- Notice Date
- 5/15/2017
- Notice Type
- Modification/Amendment
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- National Institutes of Health National Heart, Lung, and Blood Institutes Bethesda MD 20892-7511
- ZIP Code
- 20892-7511
- Solicitation Number
- HHSN26817HL00009S
- Response Due
- 5/23/2017
- Archive Date
- 6/7/2017
- Point of Contact
- Jonathan Lear
- Small Business Set-Aside
- N/A
- Description
- The NHLBI ™s Division of Intramural Research (DIR) is sponsoring a careful investigation of the Procedure in patients through a national clinical trial governed by Identifier NCT30151941, Study Number 17-H-N032 (herein referred to as Protocol). The protocol requires the participation of thirty (30) human subjects all of which must be enrolled through one of the participating enrollment sites comprised solely of structural heart disease programs located in the United States. It is neither advisable nor feasible for NHLBI to conduct the Protocol on its own; therefore, the NHLBI needs other structural heart disease programs with greater access to the target patient population to act as enrollment sites and carry out the Protocol. The objective of this project is to provide financial support for up to eight participating enrollment sites to perform its responsibilities in the Protocol and for certain costs incurred from Protocol-related activities for up to thirty (30) total patients. The purpose of the Protocol is to test the efficacy of the Procedure in patients who have no good options to treat their mitral valve failure using heart valve devices designed to implant in the aortic valve position. Each enrollment site will provide these services in accordance with the attached statement of work. There is no critical thinking required of the contractor as each site will not deviate from the statement of work provided. The data received will be provided directly to NHLBI.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/HHSN26817HL00009S/listing.html)
- Record
- SN04508681-W 20170517/170515234855-ab0ef1afc9c3d5589dbb86afeb4f8bb5 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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