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HeartMate 3 ELEVATE™ Registry (ELEVATE™)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02497950
Recruitment Status : Completed
First Posted : July 15, 2015
Last Update Posted : June 24, 2022
Sponsor:
Collaborators:
Thoratec Europe Ltd
Thoratec Corporation
Information provided by (Responsible Party):
Abbott Medical Devices

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

Condition or disease Intervention/treatment
Heart Failure Cardiovascular Disease Ventricular Dysfunction Device: HeartMate 3

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
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Study Type : Observational [Patient Registry]
Actual Enrollment : 540 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Evaluating the HeartMate 3™ in a Post-Market Approval Setting: The HeartMate 3 Registry (ELEVATE™)
Actual Study Start Date : October 13, 2015
Actual Primary Completion Date : February 2019
Actual Study Completion Date : February 28, 2022
Groups and Cohorts
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Group/Cohort Intervention/treatment
HeartMate 3
This registry will include all patients that receive the HM3 LVAS in the post-market setting
 Device: HeartMate 3
Any patient that is determined to meet the HM3 commercially approved labelling indication and that is implanted with the HM3
Other Name: HM3


Outcome Measures
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Primary Outcome Measures :
  1. Survival [ Time Frame: Up to 24 Months post-implant ]
    Patients will be followed in the registry to 24 months post-implant or outcome (transplanted, explanted for recovery or expired), whichever occurs first.


Secondary Outcome Measures :
  1. EuroQoL-5D-5L (EQ-5D-5L) [ Time Frame: Baseline, 6 months, 12 months and 24 months while the patient is being supported on the HM3 LVAS ]
    EQ-5D-5L measures self-rated health states/quality of life in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and 5 levels of severity (no problems, slight problems, moderate problems, severe problems, and extreme problems)

  2. Six Minute Walk Test (6MWT) [ Time Frame: Baseline, 6 months, 12 months and 24 months while the patient is being supported on the HM3 LVAS ]
    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.

  3. New York Heart Association (NYHA) Classification [ Time Frame: Baseline, 6 months, 12 months and 24 months while the patient is being supported on the HM3 LVAS ]
    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

  4. Adverse Events [ Time Frame: Up to 24 months ]
    Frequency and incidence of pre-defined anticipated adverse event rates

  5. Device Malfunctions [ Time Frame: Up to 24 months ]
    Frequency and incidence of device malfunction rates

  6. Reoperations [ Time Frame: Up to 24 months ]
    Frequency and incidence of reoperations after initial implant surgery

  7. Rehospitalizations [ Time Frame: Up to 24 months ]
    Frequency and incidence of rehospitalizations after initial discharge from implant surgery


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients that receive the HeartMate 3 LVAS in the post-approval setting
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02497950


Locations
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Sponsors and Collaborators
Abbott Medical Devices
Thoratec Europe Ltd
Thoratec Corporation
Investigators
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Study Director: Carlo Gazzola Abbott
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT02497950    
Other Study ID Numbers: HeartMate 3™ Registry
First Posted: July 15, 2015    Key Record Dates
Last Update Posted: June 24, 2022
Last Verified: June 2022
Keywords provided by Abbott Medical Devices:
HeartMate 3
LVAS
LVAD
Heart-assist devices
Thoratec Corporation
Additional relevant MeSH terms:
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Cardiovascular Diseases
Ventricular Dysfunction
Heart Diseases