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| Name | Class |
|---|---|
| Thoratec Europe Ltd | INDUSTRY |
| Thoratec Corporation | INDUSTRY |
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Evaluate real-world experience of HeartMate 3 (HM3) in post-approval setting.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HeartMate 3 | This registry will include all patients that receive the HM3 LVAS in the post-market setting |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HeartMate 3 | Device | Any patient that is determined to meet the HM3 commercially approved labelling indication and that is implanted with the HM3 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline, 1, 2, 3, 4, 5 years while the patient is being supported on the HM3 LVAS |
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Inclusion:
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All patients that receive the HeartMate 3 LVAS in the post-approval setting
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| Name | Affiliation | Role |
|---|---|---|
| Finn Gustafsson, MD, PhD | Rigshospitalet, Denmark | Principal Investigator |
| Jens Garbade, MD, PhD | Gesundheit Nord Klinikverbund Bremen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AJH - Wien | Vienna | 1090 | Austria | |||
| Institute for Clinical and Experimental Medicine (IKEM) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41871602 | Derived | 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. | |
| 33107561 |
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The ELEVATE study included 540 subjects of which: 482 implanted patients who provided informed consent, and 58 implanted patients had an outcome prior to having the possibility to sign the Informed Consent. For those, no patient data was collected, only duration of support and type of outcome (limited information available)
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| ID | Title | Description |
|---|---|---|
| FG000 | Elevate Full Cohort | The ELEVATE study included 540 subjects of which: 482 implanted patients who provided informed consent, and 58 implanted patients had an outcome prior to having the possibility to sign the Informed Consent. For those, no patient data was collected, only duration of support and type of outcome (limited information available) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 20, 2019 |
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| 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. |
| 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 | 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) | Up to 5 years post-implant |
| Device Malfunctions | Number of device malfunctions reported | Up to 5 years post-implant |
| Reoperations | Frequency and incidence of reoperations after initial implant surgery | Up to 5 years post-implant |
| Rehospitalizations | Frequency and incidence of rehospitalizations after initial discharge from implant surgery | Up to 5 years post-implant |
| Prague |
| 4 |
| Czechia |
| Rigshospitalet Copenhagen | Copenhagen | 2100 | Denmark |
| Universitatsklinikum Aachen | Aachen | 52074 | Germany |
| Herz- und Gefäßklinik Bad Neustadt a d Saale | Bad Neustadt an der Saale | 97616 | Germany |
| Herz-und Diabetes Zentrum NRW | Bad Oeynhausen | 32545 | Germany |
| Deutsches Herzzentrum Berlin | Berlin | 13353 | Germany |
| Medizinische Einrichtungen der Universitat Dusseldorf | Düsseldorf | 40225 | Germany |
| Universitäts-Herzzentrum Freiburg | Freiberg | 79106 | Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| Universitätsklinikum Jena | Jena | 07740 | Germany |
| Herzentrum Leipzig GmbH | Leipzig | 04280 | Germany |
| Universitätsklinikum Schleswig Holstein | Lübeck | 23538 | Germany |
| Otto-von-Guericke-Universitat Magdeburg | Magdeburg | 39120 | Germany |
| Universitätsklinikum Tübingen | Tübingen | 72076 | Germany |
| Sheba Medical Center | Tel Aviv | 52621 | Israel |
| Ospedale San Raffaele | Milan | 20132 | Italy |
| Az. Osp. San Camillo Forlanini | Roma | 00152 | Italy |
| Ospedale Civile Maggiore di Verona Borgo Trento | Verona | 37126 | Italy |
| National Research Center for Cardiac Surgery | Astana | 010000 | Kazakhstan |
| Erasmus MC - Thoraxcenter | Rotterdam | 3015 | Netherlands |
| UMC Utrecht | Utrecht | 3584 | Netherlands |
| Warsaw Institute of Cardiology | Warsaw | 02-943 | Poland |
| National Heart Centre Singapore | Singapore | 169609 | Singapore |
| Queen Elizabeth Hospital | Birmingham | B15 2TH | United Kingdom |
| Wythenshawe Hospital | Manchester | M23 9LT | United Kingdom |
| 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. |
| 30291831 | 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. |
| 30165521 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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Out of the 540 enrolled patients, baseline data were not collected for 58 subjects
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| ID | Title | Description |
|---|---|---|
| BG000 | ELEVATE Consented and Implanted Patients | Patients who received HM3 and provided informed consent |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| NYHA Class | The New York Heart Association (NYHA) Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories Class I - No symptoms and no limitation in ordinary physical activity Class II - Mild symptoms and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest. Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients. | Count of Participants | Participants |
| ||||||||||||||||||||||
| INTERMACS Profile | INTERMACS Profiles describe the Heart Failure stage of the patients:
| Count of Participants | Participants |
| ||||||||||||||||||||||
| Indication | The intended use of the device is either long-term (Destination Therapy), short term until a heart donor becomes available (bridge to transplant), or other. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Survival | Patients will be followed in the registry to 5 years post-implant or outcome (transplanted, explanted for recovery or expired), whichever occurs first. | The ELEVATE Study included 540 subjects of which: 482 received HM3 and provided informed consent, while 58 implanted patients had an outcome prior to having the possibility to sign the Informed Consent. For those, no patient data was collected, only duration of support and type of outcome (limited information available) | Posted | Count of Participants | Participants | Up to 5 Years post-implant |
|
|
| ||||||||||||||||||||||||||
| Secondary | 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). | Out of 540 enrolled patients, secondary outcome data were not collected for 58 patients | Posted | Mean | Standard Deviation | score on a scale | Baseline, 1, 2, 3, 4, 5 years while the patient is being supported on the HM3 LVAS |
|
| ||||||||||||||||||||||||||
| Secondary | 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. | The test was collected only if performed as per center's Standard of Care. | Posted | Mean | Standard Deviation | meters | At 5 years after implant |
|
| ||||||||||||||||||||||||||
| Secondary | 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 | Patients who received HM3 as either a primary implant and patients who received the HM3 or a replacement of another durable LVAD | Posted | Number | participants | At 5 years after implant |
|
| |||||||||||||||||||||||||||
| Secondary | Adverse Events | Frequency and incidence of pre-defined anticipated adverse event rates for patients with available data (primary implant and pump exchanges) | The ELEVATE study included 540 subjects of which: 482 implanted patients who provided informed consent, and 58 implanted patients had an outcome prior to having the possibility to sign the Informed Consent. For those, no patient data was collected, only duration of support and type of outcome (limited information available) | Posted | Count of Participants | Participants | Up to 5 years post-implant |
|
| |||||||||||||||||||||||||||
| Secondary | Device Malfunctions | Number of device malfunctions reported | The ELEVATE study included 540 subjects of which: 482 implanted patients who provided informed consent, and 58 implanted patients had an outcome prior to having the possibility to sign the Informed Consent. For those, no patient data was collected, only duration of support and type of outcome (limited information available) | Posted | Number | events | Up to 5 years post-implant |
|
| |||||||||||||||||||||||||||
| Secondary | Reoperations | Frequency and incidence of reoperations after initial implant surgery | The ELEVATE study included 540 subjects of which: 482 implanted patients who provided informed consent, and 58 implanted patients had an outcome prior to having the possibility to sign the Informed Consent. For those, no patient data was collected, only duration of support and type of outcome (limited information available) | Posted | Number | number of reoperation events | Up to 5 years post-implant |
|
| |||||||||||||||||||||||||||
| Secondary | Rehospitalizations | Frequency and incidence of rehospitalizations after initial discharge from implant surgery | The ELEVATE study included 540 subjects of which: 482 implanted patients who provided informed consent, and 58 implanted patients had an outcome prior to having the possibility to sign the Informed Consent. For those, no patient data was collected, only duration of support and type of outcome (limited information available) | Posted | Number | number of rehospitalization events | Up to 5 years post-implant |
|
|
Up to 5 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ELEVATE Patients | The ELEVATE study included 540 subjects of which: 463 pts received HM3 as primary implant and 19 pts received the HM3 as a replacement of another durable LVAD. These 2 groups ( 482 pts) consist the main study population, for which complete information has been collected. In addition, 58 patients had an outcome prior to having the possibility to sign the Informed Consent. For those, no patient data was collected, only duration of support and type of outcome (limited information available) | 209 | 540 | 407 | 482 | 277 | 482 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arterial Non-CNS Thromboembolism | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac Arrhythmias | Cardiac disorders | Systematic Assessment |
| ||
| Hemolysis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Hepatic Dysfunction | Hepatobiliary disorders | Systematic Assessment |
| ||
| Major Bleeding | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Major Infection | Infections and infestations | Systematic Assessment |
| ||
| Myocardial Infarction | Cardiac disorders | Systematic Assessment |
| ||
| Neurologic Dysfunction | Nervous system disorders | Systematic Assessment |
| ||
| Pericardial Fluid Collection | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Psychiatric Episode | Psychiatric disorders | Systematic Assessment |
| ||
| Renal Dysfunction | Renal and urinary disorders | Systematic Assessment |
| ||
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Right Heart Failure | Cardiac disorders | Systematic Assessment |
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| Venous Thromboembolism | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Wound Dehiscence | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Other events | General disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Arrhythmias | Cardiac disorders | Systematic Assessment |
| ||
| Hemolysis | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Hepatic Dysfunction | Hepatobiliary disorders | Systematic Assessment |
| ||
| Hypertension | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Major Bleeding | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Major Infection | Infections and infestations | Systematic Assessment |
| ||
| Neurologic Dysfunction | Nervous system disorders | Systematic Assessment |
| ||
| Pericardial Fluid Collection | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Psychiatric Episode | Psychiatric disorders | Systematic Assessment |
| ||
| Renal Dysfunction | Renal and urinary disorders | Systematic Assessment |
| ||
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Right Heart Failure | Cardiac disorders | Systematic Assessment |
| ||
| Venous Thromboembolism | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Wound Dehiscence | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Other Non Serious Events | General disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Finn Gustafsson | Rigshospitalet Copenhagen, Denmark | +4535459743 | finn.gustafsson@regionh.dk |
| Feb 10, 2023 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 20, 2019 | Feb 10, 2023 | ICF_001.pdf |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D002318 | Cardiovascular Diseases |
| D018754 | Ventricular Dysfunction |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Singapore |
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| Czechia |
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| Denmark |
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| Poland |
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| United Kingdom |
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| Italy |
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| Israel |
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| Kazakhstan |
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| Germany |
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| Title |
|---|
| Measurements |
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| Class IIIA |
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| Class IIIB |
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| Class IV |
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| Not provided |
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| 3 |
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| 4 |
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| 5 |
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| 6 |
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| 7 |
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| Not provided |
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| Other Indication |
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