Health AI Central
Peer-Reviewed Publication
Struct Heart2026;10(11):101126.November 1, 2026Editorial

Estimands in Cardiovascular Device Trials: What Are They and Why Do They Matter?

Andrew D Althouse1, David J Cohen2,3, Graeme L Hickey1
1Medtronic, Mounds View, Minnesota, USA.
2Cardiovascular Research Foundation, New York, New York, USA.
3St. Francis Hospital, Roslyn, New York, USA.
PubMed PMC DOI PDF

Abstract

•The word "estimand" means "target of estimation".•All clinical trials implicitly have estimands, even if not explicitly defined.•Estimands can be particularly important when comparing data across trials.•Estimands are now part of official guidance documents from International Council for Harmonisation, International Organization for Standardization, and Food and Drug Administration.•Clinical tria…

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