![]() ![]() The clinical research recommended by the working group is expected to address three specific challenges given in the 2007 NHLBI Strategic Plan (see ).( 1) They are: (1) to enhance the evidence available to guide the practice of medicine, and improve public health (Challenge 2.4) (2) to accelerate the translation of basic research findings into clinical studies and trials and to promote the translation of clinical research findings back to the laboratory (Challenge 2.1) and (3) to discover biomarkers that differentiate clinically relevant disease subtypes and that identify new molecular targets for application to prevention and diagnosis-including imaging, and therapy (Challenge 1.2). While various recommendations for the trial are provided in this paper and the RFP, the specific protocol and study design for the trial will be based on responses to the RFP. This paper constitutes the consensus recommendations of the working group and a description of the request for proposals (RFP) issued by the NHLBI for the pilot trial based on those recommendations. The specific objectives of the meeting were to: (1) assess the current state of clinical utility of VADs (2) identify near and long-term opportunities for clinical research on VADs and essential components of any identified trials and (3) make specific prioritized and implementable recommendations for future clinical research involving VADs to help advance public health. The purpose of the working group was to advise the NHLBI on the treatment of advanced heart failure using VADs and how therapy for heart failure may be best advanced by clinical trials involving VADs. With this in mind, 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. With the evolution of the therapy, other potential clinical applications of VADs beyond late-stage heart failure could be considered. However, their use has increased dramatically during the past few years as a result of improved clinical results realized through superior devices and patient care. ![]() Over the past 20 years, ventricular assist devices (VADs) have become a standard therapeutic option for treating late-stage heart failure patients. ![]()
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