Clinical Trials Directory

Trials / Completed

CompletedNCT02497950

HeartMate 3 ELEVATE™ Registry

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

Status
Completed
Phase
Study type
Observational
Enrollment
540 (actual)
Sponsor
Abbott Medical Devices · Industry
Sex
All
Age
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEHeartMate 3Any patient that is determined to meet the HM3 commercially approved labelling indication and that is implanted with the HM3

Timeline

Start date
2015-10-13
Primary completion
2019-02-01
Completion
2022-02-28
First posted
2015-07-15
Last updated
2025-03-20
Results posted
2025-03-20

Locations

26 sites across 11 countries: Austria, Czechia, Denmark, Germany, Israel, Italy, Kazakhstan, Netherlands, Poland, Singapore, United Kingdom

Source: ClinicalTrials.gov record NCT02497950. Inclusion in this directory is not an endorsement.