Heart FailureELEVATE™NCT02497950
HeartMate 3 ELEVATE™ Registry
An observational study of Heart Failure and Cardiovascular Disease, run by Abbott Medical Devices at 26 sites in 11 countries.
Trial summary
Evaluate real-world experience of HeartMate 3 (HM3) in post-approval setting. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure, Cardiovascular Disease, Ventricular Dysfunction
- What is being tested?
- HeartMate 3
- Type of treatment
- Medical device
- How many people
- 540 participants
- Where
- 26 sitesin 11 countries
- Study dates
- 13 Oct 2015to 28 Feb 2022
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients that receive the HeartMate 3 LVAS in the post-approval setting
Who may be able to join
- Patient consented to registry data collection
- Patient has met the HeartMate 3 commercially approved labeling indication and is implanted with the HM3.
Who cannot join
None listed.
Trial locations and contacts
26 sites in 11 countries.
26 sites in 11 countries
Germany12 sites
Universitatsklinikum Aachen
Aachen, 52074
Herz- und Gefäßklinik Bad Neustadt a d Saale
Bad Neustadt an der Saale, 97616
Herz-und Diabetes Zentrum NRW
Bad Oeynhausen, 32545
Deutsches Herzzentrum Berlin
Berlin, 13353
Medizinische Einrichtungen der Universitat Dusseldorf
Düsseldorf, 40225
Universitäts-Herzzentrum Freiburg
Freiberg, 79106
Medizinische Hochschule Hannover
Hanover, 30625
Universitätsklinikum Jena
Jena, 07740
Herzentrum Leipzig GmbH
Leipzig, 04280
Universitätsklinikum Schleswig Holstein
Lübeck, 23538
Otto-von-Guericke-Universitat Magdeburg
Magdeburg, 39120
Universitätsklinikum Tübingen
Tübingen, 72076
Italy3 sites
Ospedale San Raffaele
Milan, 20132
Az. Osp. San Camillo Forlanini
Roma, 00152
Ospedale Civile Maggiore di Verona Borgo Trento
Verona, 37126
Netherlands2 sites
Erasmus MC - Thoraxcenter
Rotterdam, 3015
UMC Utrecht
Utrecht, 3584
United Kingdom2 sites
Queen Elizabeth Hospital
Birmingham, B15 2TH
Wythenshawe Hospital
Manchester, M23 9LT
Czechia1 site
Institute for Clinical and Experimental Medicine (IKEM)
Prague, 4
Kazakhstan1 site
National Research Center for Cardiac Surgery
Astana, 010000
About this study
Official title: Evaluating the HeartMate 3™ in a Post-Market Approval Setting: The HeartMate 3 Registry (ELEVATE™)
Evaluate real-world experience of HeartMate 3 (HM3) in post-approval setting.
Read the 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.
- Being tested
- HeartMate 3
- Keywords
- HeartMate 3, LVAS, LVAD, Heart-assist devices, Thoratec Corporation
- Medical subject headings
- Heart Failure, Cardiovascular Diseases, Ventricular Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeartMate 3Device
Also called HM3
Any patient that is determined to meet the HM3 commercially approved labelling indication and that is implanted with the HM3
| Study group | Role | What they receive |
|---|---|---|
| HeartMate 3 | This registry will include all patients that receive the HM3 LVAS in the post-market setting Receives: Device: HeartMate 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Patients will be followed in the registry to 5 years post-implant or outcome (transplanted, explanted for recovery or expired), whichever occurs first.
Measured: Up to 5 Years post-implant
Secondary outcomes (7)
EuroQoL-5D-5L (EQ-5D-5L) VAS
EuroQoL-5D-5L Visual Analog Score (VAS) measures self-rated health status/quality of life, with the patient indicating his/ger current status of health on a scale from 1 (extremely poor) to 100 (exceptionally good).
Measured: Baseline, 1, 2, 3, 4, 5 years while the patient is being supported on the HM3 LVAS
Six Minute Walk Test (6MWT)
The Six Minute Walk Test (6MWT) measures the distance that a patient can walk in a period of 6 minutes. The distance walked is measured in meters. This test measures the patients' functional status. The more meters a patient can walk over baseline indicates improvement in functional status.
Measured: At 5 years after implant
New York Heart Association (NYHA) Classification
NYHA relates symptoms to every day activities and patients quality of life. Class 1 = no limitations on physical activity Class 2 - slight limitation of physical activity Class 3 - marked limitation of physical activity Class 4 = unable to carry out any physical activity without discomfort
Measured: At 5 years after implant
Adverse Events
Frequency and incidence of pre-defined anticipated adverse event rates for patients with available data (primary implant and pump exchanges)
Measured: Up to 5 years post-implant
Device Malfunctions
Number of device malfunctions reported
Measured: Up to 5 years post-implant
Reoperations
Frequency and incidence of reoperations after initial implant surgery
Measured: Up to 5 years post-implant
Rehospitalizations
Frequency and incidence of rehospitalizations after initial discharge from implant surgery
Measured: Up to 5 years post-implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2015 (estimated)
- Study start13 Oct 2015
- Primary completionFeb 2019
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 540 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Thoratec Europe Ltd, Thoratec Corporation
- Responsible party
- Sponsor
- Investigators
- Finn Gustafsson, MD, PhD, Principal investigator, Copenhagen University Hospital, RigshospitaletJens Garbade, MD, PhD, Principal investigator, Gesundheit Nord Klinikverbund Bremen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02497950
- Sponsor's protocol ID
- HeartMate 3™ Registry
- Acronym
- ELEVATE™
- Status last verified
- Apr 2024
- First submitted
- 3 Jul 2015
- Last updated
- 20 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Farber G, Zimpfer D, Garbade J, Lavee J, Morshuis M, Shaw S, Gustafsson F, Gazzola C, Wang A, Saeed D; ELEVATE Investigators. Concomitant Tricuspid Valve Surgery During HeartMate 3 LVAD Implantation and Long-Term Outcomes: Insights From the ELEVATE Registry. Eur J Cardiothorac Surg. 2026 Apr 1;68(4):ezag106. doi: 10.1093/ejcts/ezag106.
PubMed 41871602Zimpfer 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.
PubMed 33107561Garbade 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.
PubMed 30291831Gustafsson 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.
PubMed 30165521
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the HeartMate 3™ in a Post-Market Approval Setting: The HeartMate 3 Registry (ELEVATE™)
- ClinicalTrials.gov ID
- NCT02497950
- Acronym / sponsor ID
- ELEVATE™ / HeartMate 3™ Registry
- Keywords
- HeartMate 3, LVAS, LVAD, Heart-assist devices, Thoratec Corporation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 540 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Collaborators
- Thoratec Europe Ltd, Thoratec Corporation
- Study start
- 13 Oct 2015 (actual)
- Primary completion
- Feb 2019 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 15 Jul 2015 (estimated)
- Results
- Posted 20 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HeartMate 3 | – | Device: HeartMate 3This registry will include all patients that receive the HM3 LVAS in the post-market setting |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients that receive the HeartMate 3 LVAS in the post-approval setting
Key inclusion criteria (2 listed)
- Patient consented to registry data collection
- Patient has met the HeartMate 3 commercially approved labeling indication and is implanted with the HM3.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HeartMate 3Also: HM3Any patient that is determined to meet the HM3 commercially approved labelling indication and that is implanted with the HM3 | Device | HeartMate 3 |
Primary outcome
Survival
Time frame: Up to 5 Years post-implant
Patients will be followed in the registry to 5 years post-implant or outcome (transplanted, explanted for recovery or expired), whichever occurs first.
7 secondary outcomes
EuroQoL-5D-5L (EQ-5D-5L) VAS
Time frame: Baseline, 1, 2, 3, 4, 5 years while the patient is being supported on the HM3 LVAS
Six Minute Walk Test (6MWT)
Time frame: At 5 years after implant
New York Heart Association (NYHA) Classification
Time frame: At 5 years after implant
Adverse Events
Time frame: Up to 5 years post-implant
Device Malfunctions
Time frame: Up to 5 years post-implant
Reoperations
Time frame: Up to 5 years post-implant
Rehospitalizations
Time frame: Up to 5 years post-implant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41871602Farber G, Zimpfer D, Garbade J, Lavee J, Morshuis M, Shaw S, Gustafsson F, Gazzola C, Wang A, Saeed D; ELEVATE Investigators. Concomitant Tricuspid Valve Surgery During HeartMate 3 LVAD Implantation and Long-Term Outcomes: Insights From the ELEVATE Registry. Eur J Cardiothorac Surg. 2026 Apr 1;68(4):ezag106. doi: 10.1093/ejcts/ezag106.
- Derived from this study: PubMed 33107561Zimpfer 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.
- Derived from this study: PubMed 30291831Garbade 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.
- Derived from this study: PubMed 30165521Gustafsson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Finn Gustafsson, MD, PhD principal investigator
Copenhagen University Hospital, Rigshospitalet
Jens Garbade, MD, PhD principal investigator
Gesundheit Nord Klinikverbund Bremen
26 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Cardiovascular Disease, run by Abbott Medical Devices at 26 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Germany, Italy, Netherlands, United Kingdom, Austria and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: Up to 5 Years post-implant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02497950, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025; AzTrials last refreshed its copy on 27 Oct 2026.