MODIFICATION
A -- Daily Activity Measured with Accelerometry in a Clinical Trial: Transcatheter Aortic Valve Replacement to Unload the Left Ventricle in Patients with Advanced Heart Failure (TAVR UNLOAD) - Amendment 1
- Notice Date
- 12/19/2016
- Notice Type
- Modification/Amendment
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Mental Health, Contracts Management Branch, 6001 Executive Blvd, Rm 8154, MSC 9661, Bethesda, Maryland, 20892-9661
- ZIP Code
- 20892-9661
- Solicitation Number
- HHS-NIH-NIDA(AG)-RDSS-16-024
- Archive Date
- 1/26/2017
- Point of Contact
- Heather Orandi, Phone: 301-443-6162, Yvette Brown, Phone: 301 443-2696
- E-Mail Address
-
Heather.Orandi@nih.gov, Yvette.Brown@nih.gov
(Heather.Orandi@nih.gov, Yvette.Brown@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Statement of Work (SOW) THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION DOCUMENT WILL NOT BE ISSUED AND PROPOSALS WILL NOT BE REQUESTED. The National Institutes of Health, National Institute on Aging (NIA) intends to negotiate, under authority of Federal Acquisition Regulation (FAR) 6.302-1, on a noncompetitive, sole source basis with the Cardiovascular Research Foundation, New York, New York for the following requirement: Daily Activity Measured with Accelerometry in a Clinical Trial: Transcatheter Aortic Valve Replacement to Unload the Left Ventricle in Patients with Advanced Heart Failure (TAVR UNLOAD). The government will use procedures in FAR Part 15, Contracting by Negotiations. The North American Industry Classification System (NAICS) Code will be 541712 (1,000 employees). This effort will be for a period of two (2) years beginning on or about June 13, 2017. The statutory authority permitting other than full and open competition 41 United States Code (U.S.C.) 253(c)(1) as set forth in FAR 6.302-1. The Cardiovascular Research Foundation is uniquely qualified to conduct this study as they are a well-known independent organization that coordinates clinical trials in the area of cardiovascular research. In addition, the Cardiovascular Research Foundation is conducting large clinical trials related to transarterial catheterization for aortic stenosis, the condition that NIA will be studying. The purpose of this requirement is to estimate the change in daily activity over time, comparing patients with aortic valvular disease and congestive heart failure who are randomized, to either optimal therapy for congestive heart disease or to transcatheter replacement of their aortic valve combined with optimal therapy for congestive heart disease. Currently, there are few trials using accelerometry that longitudinally characterize change in daily activity over the course of the trial. The goals of adding an ancillary study with accelerometry are several-fold. First, the ancillary study would provide data regarding the central question of the trial-over the course of the trial, with ascertainment periods at one (1) month, six (6) months, one (1) year, and two (2) years; will daily activity be greater in subjects who have had their valve replaced via a transcatheter approach? Secondly, will sleep quality and indicators of circadian rhythm be better preserved in subjects with congestive heart failure who are randomized to treatment with aortic valve replacement? The repeated objective monitoring data in the trial will provide specific information on change in activity volume, duration, intensity and distribution that also will allow study of hypotheses regarding the natural history of congestive failure and change in function over time as well as change in function and recovery related to TAVR UNLOAD. Lastly, the ancillary study accelerometry data will allow assessment of whether there is utility in the larger question of inclusion of objective monitoring within clinical trials, given the many other measurements of functional status included in the trial. This requirement needs to be carried out in the context of a clinical trial in which there is, a) a patient population with congestive heart failure and aortic stenosis, and b) a patient population randomized to test the safety and efficacy of TAVR via a transfemoral approach in the setting of congestive heart failure. This study should have functional measurements to which objective monitoring can be compared in terms of what novel information it can bring to clinical trial outcomes. Since this is a sole source requirement, the solicitation will not be made available through FedBizOpps (FBO). However, the solicitation can be obtained by sending an electronic request (via email) to Heather Orandi at Heather.Orandi@nih.gov. In return, the requestor will receive a copy of the solicitation in an adobe format. In addition, a draft Statement of Work is attached for further clarification of this requirement. All requests must be sent no later than 12:00 P.M. (EST) on January 11, 2017. Otherwise, the government will not be obligated to respond to requests after the above mentioned due date. No telephone or facsimile responses will be accepted. This proposed acquisition was previously publicized under sources sought notices HHS-NIH-NIDA(AG)-RDSS-16-024 and HHS-NIH-NIDA(AG)-SBSS-16-024.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIMH/HHS-NIH-NIDA(AG)-RDSS-16-024/listing.html)
- Place of Performance
- Address: To be determined., United States
- Record
- SN04355058-W 20161221/161219234345-5fde0b01f5d3b2533dd863222b904986 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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