HeartMate 3 ELEVATE™ Registry

Abbott Medical Devices540 enrolled

Overview

Evaluate real-world experience of HeartMate 3 (HM3) in post-approval setting.

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

Enrollment

540

Conditions

Heart Failure Cardiovascular Disease Ventricular Dysfunction

Interventions

HeartMate 3DEVICE

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (26)

AJH - Wien

Vienna, Austria

Outcomes

Primary Outcomes

Survival

Patients will be followed in the registry to 5 years post-implant or outcome (transplanted, explanted for recovery or expired), whichever occurs first.

Time frame: Up to 5 Years post-implant

Secondary Outcomes

EuroQoL-5D-5L (EQ-5D-5L) VAS

EuroQoL-5D-5L Visual Analog Score (VAS) measures self-rated health status/quality of life, with the patient indicating his/ger current status of health on a scale from 1 (extremely poor) to 100 (exceptionally good).

Time frame: Baseline, 1, 2, 3, 4, 5 years while the patient is being supported on the HM3 LVAS

Six Minute Walk Test (6MWT)

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.

Time frame: At 5 years after implant

New York Heart Association (NYHA) Classification

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

Time frame: At 5 years after implant

Adverse Events

Frequency and incidence of pre-defined anticipated adverse event rates for patients with available data (primary implant and pump exchanges)

Time frame: Up to 5 years post-implant

Device Malfunctions

Number of device malfunctions reported

Data from ClinicalTrials.gov

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