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This article was originally published in The Gray Sheet

Executive Summary

ABCD trial comparing Cambridge Heart's Heartwave microvolt T-wave alternans (MTWA) system to standard invasive electrophysiology tests for sudden cardiac death risk completes enrollment, sponsor St. Jude Medical announces Sept. 13. The 540-patient trial began in 2001. St. Jude is sponsoring the trial because "the availability of a proven, non-invasive test for this at-risk group may help more patients receive life-saving implantable cardioverter defibrillator therapy," St. Jude VP-Cardiac Rhythm Management Regulatory Affairs Eric Fain explains in a release. Medtronic offers a similar justification for its MASTER trial of the Heartwave system (1"The Gray Sheet" July 14, 2003, p. 32)...

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