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HeartMate 3 ELEVATE™ (ELEVATE™)

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ClinicalTrials.gov Identifier: NCT02497950
Recruitment Status : Active, not recruiting
First Posted : July 15, 2015
Last Update Posted : July 25, 2019
Sponsor:
Collaborators:
Thoratec Europe Ltd
Thoratec Corporation
Information provided by (Responsible Party):
Abbott Medical Devices

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.

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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
Estimated Study Completion Date : April 2022

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




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



Information from the National Library of Medicine

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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.

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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Austria
AJH - Wien
Vienna, Austria, 1090
Czechia
Institute for Clinical and Experimental Medicine (IKEM)
Prague, Czechia, 4
Denmark
Rigshospitalet Copenhagen
Copenhagen, Denmark, 2100
Germany
Universitatsklinikum Aachen
Aachen, Germany, 52074
Herz- und Gefäßklinik Bad Neustadt a d Saale
Bad Neustadt an der Saale, Germany, 97616
Herz-und Diabetes Zentrum NRW
Bad Oeynhausen, Germany, 32545
Deutsches Herzzentrum Berlin
Berlin, Germany, 13353
Medizinische Einrichtungen der Universitat Dusseldorf
Dusseldorf, Germany, 40225
Universitäts-Herzzentrum Freiburg
Freiberg, Germany, 79106
Medizinische Hochschule Hannover
Hannover, Germany, 30625
Universitätsklinikum Jena
Jena, Germany, 07740
Herzentrum Leipzig GmbH
Leipzig, Germany, 04280
Universitätsklinikum Schleswig Holstein
Lubeck, Germany, 23538
Otto-von-Guericke-Universitat Magdeburg
Magdeburg, Germany, 39120
Universitätsklinikum Tübingen
Tubingen, Germany, 72076
Israel
Sheba Medical Center
Tel Aviv, Israel, 52621
Italy
Ospedale San Raffaele
Milano, Italy, 20132
Az. Osp. San Camillo Forlanini
Roma, Italy, 00152
Ospedale Civile Maggiore di Verona Borgo Trento
Verona, Italy, 37126
Kazakhstan
National Research Center for Cardiac Surgery
Astana, Kazakhstan, 010000
Netherlands
Erasmus MC - Thoraxcenter
Rotterdam, Netherlands, 3015
UMC Utrecht
Utrecht, Netherlands, 3584
Poland
Warsaw Institute of Cardiology
Warsaw, Poland, 02-943
Singapore
National Heart Centre Singapore
Singapore, Singapore, 169609
United Kingdom
Queen Elizabeth Hospital
Birmingham, United Kingdom, B15 2TH
Wythenshawe Hospital
Manchester, United Kingdom, M23 9LT
Sponsors and Collaborators
Abbott Medical Devices
Thoratec Europe Ltd
Thoratec Corporation
Investigators
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Study Director: Laura Damme, BSN, MPH Thoratec, LLC

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     History of Changes
Other Study ID Numbers: HeartMate 3™ Registry
First Posted: July 15, 2015    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019
Keywords provided by Abbott Medical Devices:
HeartMate 3
LVAS
LVAD
Heart-assist devices
Thoratec Corporation
Additional relevant MeSH terms:
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Ventricular Dysfunction
Cardiovascular Diseases
Heart Diseases