HeartMate 3 ELEVATE™ Registry (ELEVATE™)

• ClinicalTrials.gov Identifier: NCT02497950
• Recruitment Status: Completed
• First Posted: July 15, 2015
• Last Update Posted: June 24, 2022
• Sponsor: Abbott Medical Devices
• Collaborators: Thoratec Europe Ltd; Thoratec Corporation
• Information provided by (Responsible Party): Abbott Medical Devices

Tracking Information

• First Submitted Date: July 3, 2015
• First Posted Date: July 15, 2015
• Last Update Posted Date: June 24, 2022
• Actual Study Start Date: October 13, 2015
• Actual Primary Completion Date: February 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 10, 2015)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 10, 2015)

• 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)
• 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.
• 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
• Adverse Events [ Time Frame: Up to 24 months ]
  Frequency and incidence of pre-defined anticipated adverse event rates
• Device Malfunctions [ Time Frame: Up to 24 months ]
  Frequency and incidence of device malfunction rates
• Reoperations [ Time Frame: Up to 24 months ]
  Frequency and incidence of reoperations after initial implant surgery
• Rehospitalizations [ Time Frame: Up to 24 months ]
  Frequency and incidence of rehospitalizations after initial discharge from implant surgery

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: HeartMate 3 ELEVATE™ Registry
• Official Title: Evaluating the HeartMate 3™ in a Post-Market Approval Setting: The HeartMate 3 Registry (ELEVATE™)
• 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.
• Study Type: Observational [Patient Registry]
• Study Design: Observational Model: Other; Time Perspective: Prospective
• Target Follow-Up Duration: 2 Years
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: All patients that receive the HeartMate 3 LVAS in the post-approval setting

Condition

• Heart Failure
• Cardiovascular Disease
• Ventricular Dysfunction

Intervention

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

Study Groups/Cohorts

HeartMate 3

This registry will include all patients that receive the HM3 LVAS in the post-market setting

Intervention: Device: HeartMate 3

Publications *

• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 18, 2018): 540
• Original Estimated Enrollment (submitted: July 10, 2015): 500
• Actual Study Completion Date: February 28, 2022
• Actual Primary Completion Date: February 2019 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Austria, Czechia, Denmark, Germany, Israel, Italy, Kazakhstan, Netherlands, Poland, Singapore, United Kingdom
• Removed Location Countries: Czech Republic

Administrative Information

• NCT Number: NCT02497950
• Other Study ID Numbers: HeartMate 3™ Registry
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Abbott Medical Devices
• Original Responsible Party: Thoratec Corporation
• Current Study Sponsor: Abbott Medical Devices
• Original Study Sponsor: Thoratec Corporation

Collaborators

• Thoratec Europe Ltd
• Thoratec Corporation

Investigators

• Study Director: Carlo Gazzola; Abbott

• PRS Account: Abbott Medical Devices
• Verification Date: June 2022