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Clinical Trials/NCT02497950
NCT02497950CompletedNot Applicable

Evaluating the HeartMate 3™ in a Post-Market Approval Setting: The HeartMate 3 Registry (ELEVATE™)

Abbott Medical Devices26 sites in 11 countries540 target enrollmentStarted: October 13, 2015Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
540
Locations
26
Primary Endpoint
Survival
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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 Design

Study Type
Observational
Observational Model
Other
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • EuroQoL-5D-5L (EQ-5D-5L) VAS(Baseline, 1, 2, 3, 4, 5 years while the patient is being supported on the HM3 LVAS)
  • Six Minute Walk Test (6MWT)(At 5 years after implant)
  • New York Heart Association (NYHA) Classification(At 5 years after implant)
  • Adverse Events(Up to 5 years post-implant)
  • Device Malfunctions(Up to 5 years post-implant)
  • Reoperations(Up to 5 years post-implant)
  • Rehospitalizations(Up to 5 years post-implant)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (26)

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