Study Results
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View full resultsBasic Information
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COMPLETED
540 participants
OBSERVATIONAL
2015-10-13
2022-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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HeartMate 3
This registry will include all patients that receive the HM3 LVAS in the post-market setting
HeartMate 3
Any patient that is determined to meet the HM3 commercially approved labelling indication and that is implanted with the HM3
Interventions
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HeartMate 3
Any patient that is determined to meet the HM3 commercially approved labelling indication and that is implanted with the HM3
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patient has met the HeartMate 3 commercially approved labeling indication and is implanted with the HM3.
ALL
No
Sponsors
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Thoratec Europe Ltd
INDUSTRY
Thoratec Corporation
INDUSTRY
Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Finn Gustafsson, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, Denmark
Jens Garbade, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Gesundheit Nord Klinikverbund Bremen
Locations
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AJH - Wien
Vienna, , Austria
Institute for Clinical and Experimental Medicine (IKEM)
Prague, , Czechia
Rigshospitalet Copenhagen
Copenhagen, , Denmark
Universitatsklinikum Aachen
Aachen, , Germany
Herz- und Gefäßklinik Bad Neustadt a d Saale
Bad Neustadt an der Saale, , Germany
Herz-und Diabetes Zentrum NRW
Bad Oeynhausen, , Germany
Deutsches Herzzentrum Berlin
Berlin, , Germany
Medizinische Einrichtungen der Universitat Dusseldorf
Düsseldorf, , Germany
Universitäts-Herzzentrum Freiburg
Freiberg, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Universitätsklinikum Jena
Jena, , Germany
Herzentrum Leipzig GmbH
Leipzig, , Germany
Universitätsklinikum Schleswig Holstein
Lübeck, , Germany
Otto-von-Guericke-Universitat Magdeburg
Magdeburg, , Germany
Universitätsklinikum Tübingen
Tübingen, , Germany
Sheba Medical Center
Tel Aviv, , Israel
Ospedale San Raffaele
Milan, , Italy
Az. Osp. San Camillo Forlanini
Roma, , Italy
Ospedale Civile Maggiore di Verona Borgo Trento
Verona, , Italy
National Research Center for Cardiac Surgery
Astana, , Kazakhstan
Erasmus MC - Thoraxcenter
Rotterdam, , Netherlands
UMC Utrecht
Utrecht, , Netherlands
Warsaw Institute of Cardiology
Warsaw, , Poland
National Heart Centre Singapore
Singapore, , Singapore
Queen Elizabeth Hospital
Birmingham, , United Kingdom
Wythenshawe Hospital
Manchester, , United Kingdom
Countries
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References
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Zimpfer D, Gustafsson F, Potapov E, Pya Y, Schmitto J, Berchtold-Herz M, Morshuis M, Shaw SM, Saeed D, Lavee J, Heatley G, Gazzola C, Garbade J. Two-year outcome after implantation of a full magnetically levitated left ventricular assist device: results from the ELEVATE Registry. Eur Heart J. 2020 Oct 14;41(39):3801-3809. doi: 10.1093/eurheartj/ehaa639.
Garbade J, Gustafsson F, Shaw S, Lavee J, Saeed D, Pya Y, Krabatsch T, Schmitto JD, Morshuis M, Chuang J, Zimpfer D. Postmarket Experience With HeartMate 3 Left Ventricular Assist Device: 30-Day Outcomes From the ELEVATE Registry. Ann Thorac Surg. 2019 Jan;107(1):33-39. doi: 10.1016/j.athoracsur.2018.07.092. Epub 2018 Oct 3.
Gustafsson F, Shaw S, Lavee J, Saeed D, Pya Y, Krabatsch T, Schmitto J, Morshuis M, Chuang J, Damme L, Zimpfer D, Garbade J. Six-month outcomes after treatment of advanced heart failure with a full magnetically levitated continuous flow left ventricular assist device: report from the ELEVATE registry. Eur Heart J. 2018 Oct 1;39(37):3454-3460. doi: 10.1093/eurheartj/ehy513.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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HeartMate 3™ Registry
Identifier Type: -
Identifier Source: org_study_id
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