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

Abbott Medical Devices26 sites in 11 countries540 target enrollmentOctober 13, 2015

ConditionsHeart Failure Cardiovascular Disease Ventricular Dysfunction

Overview

Phase: N/A
Intervention: Not specified
Conditions: Heart Failure
Sponsor: Abbott Medical Devices
Enrollment: 540
Locations: 26
Primary Endpoint: Survival
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

October 13, 2015

End Date

February 28, 2022

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Abbott Medical Devices

Responsible Party

Sponsor

Eligibility Criteria

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)