SOLICITATION NOTICE
B -- Gender-Specific Predictors of Heart Failure Hospitalization and Death in Cardiac Resynchronization Therapy - Solicitation
- Notice Date
- 8/17/2012
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-SOL-1105442
- Archive Date
- 9/12/2012
- Point of Contact
- Sean Wybenga, Phone: 301-827-6761, Doreen Williams,
- E-Mail Address
-
sean.wybenga@fda.hhs.gov, doreen.williams@fda.hhs.gov
(sean.wybenga@fda.hhs.gov, doreen.williams@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Request for Quote The primary purpose of this project is to utilize real world data from a large registry of patients receiving cardiac resynchronization therapy defibrillators (CRT-D) to develop and analyze new, gender-specific predictors of clinical outcomes. Using a large registry of CRT-D patients will allow for the development of better patient selection criteria, especially for women who are frequently underrepresented in the clinical trials.1 The large registry should also include patients receiving non-CRT implantable cardioverter defibrillators (ICD), which will be used as a comparison group in certain analyses. The development of improved patient selection criteria will improve the safety and efficacy of these devices for both genders by better identifying patients likely to respond and limiting the risk of procedural complications to patients unlikely to benefit.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-SOL-1105442/listing.html)
- Record
- SN02844096-W 20120819/120817235115-d382ebda96dad222b22e2102bf0badc5 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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