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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03022461




Registration number
NCT03022461
Ethics application status
Date submitted
12/01/2017
Date registered
16/01/2017
Date last updated
27/06/2022

Titles & IDs
Public title
HeartMate 3 CE Mark Study Long Term Follow-up
Scientific title
HeartMate 3 CE Mark Study Long Term Follow-up Clinical Investigation Plan
Secondary ID [1] 0 0
HeartMate 3 CE Mark Study LTFU
Universal Trial Number (UTN)
Trial acronym
HM3 CE LTFU
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Refractory Left Ventricular Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Ongoing HM3 CE Mark study patients - The study will include the ongoing HM3 CE Mark study patients that have consented to continue the long term follow-up data collection.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Survival
Assessment method [1] 0 0
Subject outcomes and survival over time
Timepoint [1] 0 0
At 5 years post HM3 CE Mark study implant
Secondary outcome [1] 0 0
EuroQoL 5D-5L (EQ-5D-5L) VAS Score
Assessment method [1] 0 0
Quality of Life over time as measured by EuroQoL 5D-5L (EQ-5D-5L) VAS Score. The Visual Analog Scale (VAS) records the respondent's self-rated health status on a graduated (0-100) scale, with higher scores for higher quality of life
Timepoint [1] 0 0
At 5 years post HM3 CE Mark study implant
Secondary outcome [2] 0 0
Six Minute Walk Test (6MWT)
Assessment method [2] 0 0
Functional status over time as measured by the Six Minute Walk Test (6MWT). The 6MWT is done to establish the amount of meters a subject can walk in 6 minutes
Timepoint [2] 0 0
At 5 years post HM3 CE Mark study implant
Secondary outcome [3] 0 0
New York Heart Association (NYHA)
Assessment method [3] 0 0
Functional status over time as measured by New York Heart Association (NYHA). Patients are graded from 4 to 1 in order or symptoms: I No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath). II Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath). IIIA Marked limitation of physical activity. No dyspnea at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. IIIB Marked limitation of physical activity. Recent dyspnea at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. IV Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.
Timepoint [3] 0 0
At 5 years post HM3 CE Mark study implant
Secondary outcome [4] 0 0
Adverse Events
Assessment method [4] 0 0
Number of Participants with Adverse Events
Timepoint [4] 0 0
Between 2 and 5 years post HM3 CE Mark study implant
Secondary outcome [5] 0 0
Device Malfunctions
Assessment method [5] 0 0
Number of Participants with device malfunctions
Timepoint [5] 0 0
Between 2 and 5 years post HM3 CE Mark study implant
Secondary outcome [6] 0 0
Reoperations
Assessment method [6] 0 0
Number of reoperations
Timepoint [6] 0 0
Between 2 and 5 years post HM3 CE Mark study implant
Secondary outcome [7] 0 0
Rehospitalizations
Assessment method [7] 0 0
Number of rehospitalizations
Timepoint [7] 0 0
Between 2 and 5 years post HM3 CE Mark study implant
Secondary outcome [8] 0 0
Percentage of Participants Who Survived Without Experiencing a Debilitating Stroke (MRS>3)
Assessment method [8] 0 0
Modified Rankin Score \>3 is considered debilitating. As in 3 cases the MRS evaluation was not available, a sensitivity analysis for the worst and best case scenario was performed. The MRS scale is as following: 0: No observed neurological symptoms; 1: No significant neurological disability despite symptoms; able to carry out all usual duties and activities; 2: Slight neurological disability; unable to carry out all previous activities, but able to look after own affairs without assistance; 3: Moderate neurological disability; requiring some help, but able to walk without assistance; 4: Moderate severe neurological disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; 5: Severe neurological disability; bedridden, incontinent and requiring constant nursing care and attention as a result of a neurological deficit; 6: Dead
Timepoint [8] 0 0
As it may occur up to 5 years post HM3 CE Mark study implant or to outcome, whichever occurs first

Eligibility
Key inclusion criteria
1. Patient or legal representative has signed Informed Consent Form (ICF).
2. Patient was enrolled in the HeartMate 3 CE Mark Study and continues to be supported with the HeartMate 3 LVAS after the 2 year CE Mark study follow-up.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patient does not consent to the continued data collection.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/06/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/12/2019
Sample size
Target
Accrual to date
Final
25
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Vienna
Country [2] 0 0
Canada
State/province [2] 0 0
Ontario
Country [3] 0 0
Czechia
State/province [3] 0 0
Prague
Country [4] 0 0
Germany
State/province [4] 0 0
Berlin
Country [5] 0 0
Germany
State/province [5] 0 0
Freiburg
Country [6] 0 0
Germany
State/province [6] 0 0
Hannover
Country [7] 0 0
Kazakhstan
State/province [7] 0 0
Astana

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Abbott Medical Devices
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Carlo Gazzola, B. Sc.
Address 0 0
Abbott
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT03022461