HeartMate 3 ELEVATE™ Registry

NCT02497950 | Completed Results

• 1 other identifier: HeartMate 3™ Registry
• Study Type: observational
• Target: 540
• Locations: 11 countries
• Sites: 26

Brief Summary

Evaluate real-world experience of HeartMate 3 (HM3) in post-approval setting.

Conditions

Heart Failure; Cardiovascular Disease; Ventricular Dysfunction

Keywords

HeartMate 3; LVAS; LVAD; Heart-assist devices; Thoratec Corporation

Outcome Measures

Primary Outcomes (1)

• Survival

  Patients will be followed in the registry to 5 years post-implant or outcome (transplanted, explanted for recovery or expired), whichever occurs first.

  Up to 5 Years post-implant

Secondary Outcomes (7)

• EuroQoL-5D-5L (EQ-5D-5L) VAS

  Baseline, 1, 2, 3, 4, 5 years while the patient is being supported on the HM3 LVAS

• Six Minute Walk Test (6MWT)

  At 5 years after implant

• New York Heart Association (NYHA) Classification

  At 5 years after implant

• Adverse Events

  Up to 5 years post-implant

• Device Malfunctions

  Up to 5 years post-implant

Study Arms (1)

HeartMate 3

This registry will include all patients that receive the HM3 LVAS in the post-market setting

Device: HeartMate 3

Interventions

HeartMate 3 DEVICE

Any patient that is determined to meet the HM3 commercially approved labelling indication and that is implanted with the HM3

Also known as: HM3

HeartMate 3

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients that receive the HeartMate 3 LVAS in the post-approval setting

You may qualify if:

• Patient consented to registry data collection
• Patient has met the HeartMate 3 commercially approved labeling indication and is implanted with the HM3.

Sponsors & Collaborators

• Abbott Medical Devices: lead
• Thoratec Europe Ltd: collaborator
• Thoratec Corporation: collaborator

Study Sites (26)

AJH - Wien

Vienna, 1090, Austria

Location

Institute for Clinical and Experimental Medicine (IKEM)

Prague, 4, Czechia

Location

Rigshospitalet Copenhagen

Copenhagen, 2100, Denmark

Location

Universitatsklinikum Aachen

Aachen, 52074, Germany

Location

Herz- und Gefäßklinik Bad Neustadt a d Saale

Bad Neustadt an der Saale, 97616, Germany

Location

Herz-und Diabetes Zentrum NRW

Bad Oeynhausen, 32545, Germany

Location

Deutsches Herzzentrum Berlin

Berlin, 13353, Germany

Location

Medizinische Einrichtungen der Universitat Dusseldorf

Düsseldorf, 40225, Germany

Location

Universitäts-Herzzentrum Freiburg

Freiberg, 79106, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Universitätsklinikum Jena

Jena, 07740, Germany

Location

Herzentrum Leipzig GmbH

Leipzig, 04280, Germany

Location

Universitätsklinikum Schleswig Holstein

Lübeck, 23538, Germany

Location

Otto-von-Guericke-Universitat Magdeburg

Magdeburg, 39120, Germany

Location

Universitätsklinikum Tübingen

Tübingen, 72076, Germany

Location

Sheba Medical Center

Tel Aviv, 52621, Israel

Location

Ospedale San Raffaele

Milan, 20132, Italy

Location

Az. Osp. San Camillo Forlanini

Roma, 00152, Italy

Location

Ospedale Civile Maggiore di Verona Borgo Trento

Verona, 37126, Italy

Location

National Research Center for Cardiac Surgery

Astana, 010000, Kazakhstan

Location

Erasmus MC - Thoraxcenter

Rotterdam, 3015, Netherlands

Location

UMC Utrecht

Utrecht, 3584, Netherlands

Location

Warsaw Institute of Cardiology

Warsaw, 02-943, Poland

Location

National Heart Centre Singapore

Singapore, 169609, Singapore

Location

Queen Elizabeth Hospital

Birmingham, B15 2TH, United Kingdom

Location

Wythenshawe Hospital

Manchester, M23 9LT, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 33107561 DERIVED

• 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.

  PMID: 30291831 DERIVED

• 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.

  PMID: 30165521 DERIVED

MeSH Terms

Conditions

Heart Failure; Cardiovascular Diseases; Ventricular Dysfunction

Condition Hierarchy (Ancestors)

Heart Diseases

Results Point of Contact

• Title: Prof. Finn Gustafsson
• Organization: Rigshospitalet Copenhagen, Denmark

finn.gustafsson@regionh.dk

+4535459743

Study Officials

• Finn Gustafsson, MD, PhD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

• Jens Garbade, MD, PhD

  Gesundheit Nord Klinikverbund Bremen

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2015
• First Posted: July 15, 2015
• Study Start: October 13, 2015
• Primary Completion: February 1, 2019
• Study Completion: February 28, 2022
• Last Updated: March 20, 2025
• Results First Posted: March 20, 2025

Record last verified: 2024-04

Locations

DK (1); DE (12); KA (1); CZ (1); SG (1); IT (3); NL (2); GB (2); AU (1); IL (1); PL (1)