ATS
HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS
QUICK SEARCH:   [advanced]


     

This Article
Right arrow Full Text
Right arrow Full Text (PDF)
Right arrow Alert me when this article is cited
Right arrow Alert me if a correction is posted
Right arrow Citation Map
Services
Right arrow Email this article to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Add to Personal Folders
Right arrow Download to citation manager
Right arrow Author home page(s):
Alan J. Moskowitz
Eric A. Rose
Annetine C. Gelijns
Right arrow Permission Requests
Citing Articles
Right arrow Citing Articles via HighWire
Right arrow Citing Articles via Google Scholar
Google Scholar
Right arrow Articles by Parides, M. K.
Right arrow Articles by Gelijns, A. C.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Parides, M. K.
Right arrow Articles by Gelijns, A. C.
Related Collections
Right arrow Professional affairs
Right arrow Mechanical Circulatory Assistance
Right arrowRelated Articles

Ann Thorac Surg 2006;82:1140-1146
© 2006 The Society of Thoracic Surgeons

Review

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

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

a International Center for Health Outcomes and Innovation Research, Columbia University, New York, New York
b Department of Surgery, Columbia University, New York, New York

Accepted for publication May 22, 2006.

* Address correspondence to Dr Gelijns, Columbia University, InCHOIR, 600 W 168 St, New York, NY 10032 (Email: acp10{at}columbia.edu).

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.


Related Articles

FDA Perspective on Clinical Trial Design for Cardiovascular Devices
Eric Chen, Wolf Sapirstein, Chul Ahn, Julie Swain, and Bram Zuckerman
Ann. Thorac. Surg. 2006 82: 773-775. [Extract] [Full Text] [PDF]

Prosthetic Heart Valves: Objective Performance Criteria Versus Randomized Clinical Trial
Gary L. Grunkemeier, Ruyun Jin, and Albert Starr
Ann. Thorac. Surg. 2006 82: 776-780. [Abstract] [Full Text] [PDF]



This article has been cited by other articles:


Home page
 NEJMHome page
K. L. Baughman and J. A. Jarcho
Bridge to Life -- Cardiac Mechanical Support
N. Engl. J. Med., August 30, 2007; 357(9): 846 - 849.
[Full Text] [PDF]

Home page
 Ann. Thorac. Surg.Home page
E. Chen, W. Sapirstein, C. Ahn, J. Swain, and B. Zuckerman
FDA perspective on clinical trial design for cardiovascular devices.
Ann. Thorac. Surg., September 1, 2006; 82(3): 773 - 775.
[Full Text] [PDF]


HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS
ANN THORAC SURG ASIAN CARDIOVASC THORAC ANN EUR J CARDIOTHORAC SURG
J THORAC CARDIOVASC SURG ICVTS ALL CTSNet JOURNALS
Copyright © 2006 by The Society of Thoracic Surgeons.