Last updated on April 2018

HeartMate 3 CE Mark Study Long Term Follow-up


Brief description of study

The purpose of this clinical investigation is to report the long term survival and incidence of adverse events in the patients who were implanted with HM3 in the CE Mark Study and continue to be ongoing with the HeartMate 3 LVAS after the CE Mark Study 2 year follow-up.

The study will be a single arm, prospective, multi-center, non-blinded and non-randomized study, intended to report on the long term use of the HeartMate 3 LVAS in those patients that completed the 2-year follow-up in the HeartMate 3 CE Mark study.

Clinical Study Identifier: NCT03022461

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Daniel Zimpfer, MD, PhD

AKH Medical University of Vienna
Vienna, Austria

Ivan Netuka, MD, PhD

Institute for Clinical and Experimental Medicine (IKEM)
Prague, Czech Republic

Thomas Krabatsch, MD, PhD

Deutsches Herzzentrum Berlin
Berlin, Germany

Friedhelm Beyersdorf, MD

Universitats-Herzzentrum Freiburg
Freiburg, Germany

Jan Schmitto, MD, PhD

Medizinische Hochschule Hannover
Hannover, Germany

Yuriy Pya, MD

National Research Center for Cardiac Surgery
Astana, Kazakhstan