HeartMate 3 ELEVATE™ Registry

Heart Failure Clinical Trial

— ELEVATE™  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02497950
• Other study ID #: HeartMate 3™ Registry
• Status: Completed
• Start date: October 13, 2015
• Est. completion date: February 28, 2022

Study information

• Verified date: June 2022
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 540
• Est. completion date: February 28, 2022
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Heart Failure
• 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

Locations

Country	Name	City	State
Austria	AJH - Wien	Vienna
Czechia	Institute for Clinical and Experimental Medicine (IKEM)	Prague
Denmark	Rigshospitalet Copenhagen	Copenhagen
Germany	Universitatsklinikum Aachen	Aachen
Germany	Herz- und Gefäßklinik Bad Neustadt a d Saale	Bad Neustadt an der Saale
Germany	Herz-und Diabetes Zentrum NRW	Bad Oeynhausen
Germany	Deutsches Herzzentrum Berlin	Berlin
Germany	Medizinische Einrichtungen der Universitat Dusseldorf	Dusseldorf
Germany	Universitäts-Herzzentrum Freiburg	Freiberg
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Universitätsklinikum Jena	Jena
Germany	Herzentrum Leipzig GmbH	Leipzig
Germany	Universitätsklinikum Schleswig Holstein	Lubeck
Germany	Otto-von-Guericke-Universitat Magdeburg	Magdeburg
Germany	Universitätsklinikum Tübingen	Tubingen
Israel	Sheba Medical Center	Tel Aviv
Italy	Ospedale San Raffaele	Milano
Italy	Az. Osp. San Camillo Forlanini	Roma
Italy	Ospedale Civile Maggiore di Verona Borgo Trento	Verona
Kazakhstan	National Research Center for Cardiac Surgery	Astana
Netherlands	Erasmus MC - Thoraxcenter	Rotterdam
Netherlands	UMC Utrecht	Utrecht
Poland	Warsaw Institute of Cardiology	Warsaw
Singapore	National Heart Centre Singapore	Singapore
United Kingdom	Queen Elizabeth Hospital	Birmingham
United Kingdom	Wythenshawe Hospital	Manchester

Sponsors (3)

Lead Sponsor	Collaborator
Abbott Medical Devices	Thoratec Corporation, Thoratec Europe Ltd

Countries where clinical trial is conducted

Austria,  Czechia,  Denmark,  Germany,  Israel,  Italy,  Kazakhstan,  Netherlands,  Poland,  Singapore,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	Patients will be followed in the registry to 24 months post-implant or outcome (transplanted, explanted for recovery or expired), whichever occurs first.	Up to 24 Months post-implant
Secondary	EuroQoL-5D-5L (EQ-5D-5L)	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)	Baseline, 6 months, 12 months and 24 months while the patient is being supported on the HM3 LVAS
Secondary	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.	Baseline, 6 months, 12 months and 24 months while the patient is being supported on the HM3 LVAS
Secondary	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	Baseline, 6 months, 12 months and 24 months while the patient is being supported on the HM3 LVAS
Secondary	Adverse Events	Frequency and incidence of pre-defined anticipated adverse event rates	Up to 24 months
Secondary	Device Malfunctions	Frequency and incidence of device malfunction rates	Up to 24 months
Secondary	Reoperations	Frequency and incidence of reoperations after initial implant surgery	Up to 24 months
Secondary	Rehospitalizations	Frequency and incidence of rehospitalizations after initial discharge from implant surgery	Up to 24 months