The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03022461
Ethics application status
Date submitted
12/01/2017
Date registered
16/01/2017
Date last updated
19/04/2019

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
Other interventions - Long term follow-up

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.


Other interventions: Long term follow-up


Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Survival - Subject outcomes and survival over time
Timepoint [1] 0 0
All Subjects will be followed for 3, 4 and 5 years post HM3 CE Mark study implant or to Outcome (transplant, explant, or death), whichever occurs first
Secondary outcome [1] 0 0
EuroQoL 5D-5L (EQ-5D-5L) - Quality of Life over time as measured by EuroQoL 5D-5L (EQ-5D-5L)
Timepoint [1] 0 0
3, 4 and 5 years post HM3 CE Mark study implant
Secondary outcome [2] 0 0
Six Minute Walk Test (6MWT) - Functional status over time as measured by the Six Minute Walk Test (6MWT)
Timepoint [2] 0 0
3, 4 and 5 years post HM3 CE Mark study implant
Secondary outcome [3] 0 0
New York Heart Association (NYHA) - Functional status over time as measured by New York Heart Association (NYHA)
Timepoint [3] 0 0
3, 4 and 5 years post HM3 CE Mark study implant
Secondary outcome [4] 0 0
Adverse Events - Frequency and incidence of pre-defined anticipated adverse event rates
Timepoint [4] 0 0
As they occur up to 5 years post HM3 CE Mark study implant or to outcome, whichever occurs first
Secondary outcome [5] 0 0
Device Malfunctions - Frequency and incidence of device malfunction rates
Timepoint [5] 0 0
As they occur up to 5 years post HM3 CE Mark study implant or to outcome, whichever occurs first
Secondary outcome [6] 0 0
Reoperations - Frequency and incidence of reoperations
Timepoint [6] 0 0
As they occur up to 5 years post HM3 CE Mark study implant or to outcome, whichever occurs first
Secondary outcome [7] 0 0
Rehospitalizations - Frequency and incidence of rehospitalizations
Timepoint [7] 0 0
As they occur up to 5 years post HM3 CE Mark study implant or to outcome, whichever occurs first
Secondary outcome [8] 0 0
Survival Free of Debilitating Stroke (Modified Rankin Score >3)
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
Gender
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this clinical investigation is to report the long term survival and incidence
of adverse events in the patients who were implanted with HM3 in the CE Mark Study and
continue to be ongoing with the HeartMate 3 LVAS after the CE Mark Study 2 year follow-up.

The study will be a single arm, prospective, multi-center, non-blinded and non-randomized
study, intended to report on the long term use of the HeartMate 3 LVAS in those patients that
completed the 2-year follow-up in the HeartMate 3 CE Mark study.
Trial website
https://clinicaltrials.gov/show/NCT03022461
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Poornima Sood, MD, MBA
Address 0 0
Abbott
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications