Progress Versus Precision: Challenges in Clinical Trial Design for Left Ventricular Assist Devices

Michael K. Parides, Alan J. Moskowitz, Deborah D. Ascheim, Eric A. Rose, Annetine C. Gelijns

Research output: Contribution to journalReview article

25 Scopus citations

Abstract

New left ventricular assist devices promise fewer adverse events but, currently, only minor improvements in survival. Small (survival) treatment effects, limited patient populations, and the increasing number of left ventricular assist devices in development challenge the efficient conduct of premarketing trials (especially in destination therapy) and, maybe more importantly, hamper innovation. Novel trial designs would facilitate this process. Among a range of trial designs, we opt for small randomized trials, which would preserve the advantages of randomization and also allow for a shorter enrollment period. We also advocate an evidence shift toward postmarketing studies, with the Interagency Registry of Mechanically Assisted Circulatory Support providing a robust infrastructure.

Original languageEnglish (US)
Pages (from-to)1140-1146
Number of pages7
JournalAnnals of Thoracic Surgery
Volume82
Issue number3
DOIs
Publication statusPublished - Sep 1 2006
Externally publishedYes

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ASJC Scopus subject areas

  • Surgery
  • Pulmonary and Respiratory Medicine
  • Cardiology and Cardiovascular Medicine

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