Clinical trial NCT02497950: HeartMate 3 ELEVATE™ Registry
Official title: Evaluating the HeartMate 3™ in a Post-Market Approval Setting: The HeartMate 3 Registry (ELEVATE™)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Cardiovascular Disease
Ventricular Dysfunction
Keywords: HeartMate 3
LVAS
LVAD
Heart-assist devices
Thoratec Corporation
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
Collaborators: name: Thoratec Europe Ltd
name: Thoratec Corporation
First posted: 2015-07-15
Enrollment: 540
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients that receive the HeartMate 3 LVAS in the post-approval setting

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

Detailed description: The purpose of this post-market registry is to collect data and evaluate the real-world experience of the HeartMate 3 Left Ventricular Assist System (HM3 LVAS) in a post-approval setting.

Eligibility criteria: Inclusion:

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

Primary outcomes:
measure: Survival
timeFrame: Up to 5 Years post-implant
Secondary outcomes:
measure: EuroQoL-5D-5L (EQ-5D-5L) VAS
timeFrame: Baseline, 1, 2, 3, 4, 5 years while the patient is being supported on the HM3 LVAS
measure: Six Minute Walk Test (6MWT)
timeFrame: At 5 years after implant
measure: New York Heart Association (NYHA) Classification
timeFrame: At 5 years after implant
measure: Adverse Events
timeFrame: Up to 5 years post-implant
measure: Device Malfunctions
timeFrame: Up to 5 years post-implant
measure: Reoperations
timeFrame: Up to 5 years post-implant
measure: Rehospitalizations
timeFrame: Up to 5 years post-implant
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: AJH - Wien
city: Prague
country: Czechia
facility: Institute for Clinical and Experimental Medicine (IKEM)
city: Copenhagen
country: Denmark
facility: Rigshospitalet Copenhagen
city: Aachen
country: Germany
facility: Universitatsklinikum Aachen
city: Bad Neustadt an der Saale
country: Germany
facility: Herz- und Gefäßklinik Bad Neustadt a d Saale
city: Bad Oeynhausen
country: Germany
facility: Herz-und Diabetes Zentrum NRW
city: Berlin
country: Germany
facility: Deutsches Herzzentrum Berlin
city: Dusseldorf
country: Germany
facility: Medizinische Einrichtungen der Universitat Dusseldorf
city: Freiberg
country: Germany
facility: Universitäts-Herzzentrum Freiburg
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Jena
country: Germany
facility: Universitätsklinikum Jena
city: Leipzig
country: Germany
facility: Herzentrum Leipzig GmbH
city: Lubeck
country: Germany
facility: Universitätsklinikum Schleswig Holstein
city: Magdeburg
country: Germany
facility: Otto-von-Guericke-Universitat Magdeburg
city: Tubingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Tel Aviv
country: Israel
facility: Sheba Medical Center
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: Roma
country: Italy
facility: Az. Osp. San Camillo Forlanini
city: Verona
country: Italy
facility: Ospedale Civile Maggiore di Verona Borgo Trento
city: Astana
country: Kazakhstan
facility: National Research Center for Cardiac Surgery
city: Rotterdam
country: Netherlands
facility: Erasmus MC - Thoraxcenter
city: Utrecht
country: Netherlands
facility: UMC Utrecht
city: Warsaw
country: Poland
facility: Warsaw Institute of Cardiology
city: Singapore
country: Singapore
facility: National Heart Centre Singapore
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital
city: Manchester
country: United Kingdom
facility: Wythenshawe Hospital
Study officials:
affiliation: Rigshospitalet, Denmark
name: Finn Gustafsson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gesundheit Nord Klinikverbund Bremen
name: Jens Garbade, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.