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Related Experiment Video

Updated: Jul 16, 2026

Design of a Cyclic Pressure Bioreactor for the Ex Vivo Study of Aortic Heart Valves
07:12

Design of a Cyclic Pressure Bioreactor for the Ex Vivo Study of Aortic Heart Valves

Published on: August 23, 2011

Designs for mechanical circulatory support device studies.

James D Neaton1, Sharon-Lise Normand, Annetine Gelijns

  • 1University of Minnesota School of Public Health, Minneapolis, Minnesota 55415, USA.

Journal of Cardiac Failure
|March 7, 2007
PubMed
Summary

Evaluating mechanical circulatory support devices (MCSDs) like left ventricular assist devices (LVADs) requires improved trial designs. The workshop recommended incorporating randomized elements alongside alternative designs to enhance patient enrollment and device evaluation.

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Area of Science:

  • Cardiovascular Medicine
  • Biomedical Engineering
  • Clinical Trial Design

Background:

  • Growing interest in mechanical circulatory support devices (MCSDs) for advanced heart failure.
  • Challenges in patient enrollment for randomized trials of implantable left ventricular assist devices (LVADs).

Purpose of the Study:

  • To consider innovative designs for MCSD development.
  • To explore alternatives to traditional randomized trials for evaluating new MCSDs.

Main Methods:

  • A joint workshop by the Heart Failure Society of America and US Food and Drug Administration.
  • Panel review of different designs for evaluating new MCSDs, including randomized trials and alternatives.
  • Discussion on improving randomized trial designs and considering alternative approaches.

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Last Updated: Jul 16, 2026

Design of a Cyclic Pressure Bioreactor for the Ex Vivo Study of Aortic Heart Valves
07:12

Design of a Cyclic Pressure Bioreactor for the Ex Vivo Study of Aortic Heart Valves

Published on: August 23, 2011

Use of Two Intracorporeal Ventricular Assist Devices As a Total Artificial Heart
08:49

Use of Two Intracorporeal Ventricular Assist Devices As a Total Artificial Heart

Published on: May 11, 2018

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Published on: March 1, 2016

Main Results:

  • Randomized trials offer significant advantages in eliminating bias and balancing covariates.
  • Difficulties in patient recruitment for randomized studies due to limited clinical sites and reluctance to randomize against perceived inferior controls.
  • Exploration of ways to improve randomized trial designs and evaluate alternative methodologies.

Conclusions:

  • Recommended inclusion of a randomized component in MCSD trial designs.
  • Suggested improvements include pre-randomization control selection, vanguard studies, and crossover designs.
  • Advocated for evaluating alternative designs combining randomized and non-randomized components, requiring multi-sector collaboration.