CLINICAL TRIAL OF AN IMPLANTABLE CARDIAC DEFIBRILLATOR 

NIH GUIDE, Volume 21, Number 4, January 31, 1992

 

RFP AVAILABLE:  NHLBI-HC-92-10

 

P.T. 34



Keywords:

  Prosthetic Device, Heart 

  Clinical Trial 

 

National Heart, Lung, and Blood Institute

 

The National Heart, Lung, and Blood Institute (NHLBI) requires one

institution to conduct a multicenter trial to assess whether or not the

use of an implantable cardiac defibrillator will result in reduced

total mortality in comparison to conventional pharmacologic therapy in

patients who have been resuscitated from sudden cardiac death or are

otherwise at very high risk of mortality from arrhythmic causes.  The

study will consist of a pilot phase and a full-scale trial.  Two

hundred patients will be entered into the pilot study.  If the pilot

study demonstrates that a full-scale trial is feasible, approximately

1,000 patients will be entered into the full-scale study.

 

The period of performance is anticipated for 89 months beginning in

September 1992.

 

This is a notice of availability of a Request for Proposals (RFP).  RFP

NHLBI-HC-92-10 will be available on or about January 28, 1992, with

proposals due April 4, 1992.  One award is anticipated by the

Government.  Only North American offeror institutions will be

considered.  Written requests for the RFP must include three mailing

labels, self-addressed, and must cite RFP NHLBI-HC-92-10.

 

Requests for copies of the RFP are to be sent to:

 

Cheryl A. Jennings

Contracting Officer for ECA Contracts Section

National Heart, Lung, and Blood Institute

Federal Building, Room 3C16

Bethesda, MD  20892

 

.

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