Advanced Refractory Left Ventricular Heart FailureHM3 CE LTFUNCT03022461
HeartMate 3 CE Mark Study Long Term Follow-up
An observational study of Advanced Refractory Left Ventricular Heart Failure, run by Abbott Medical Devices at 8 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Refractory Left Ventricular Heart Failure
- What is being tested?
- Long term follow-up
- How many people
- 25 participants
- Where
- 8 sitesin 6 countries
- Study dates
- 23 Jun 2014to 12 Dec 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with advanced refractory left ventricular heart failure who were implanted with HeartMate 3 in the CE Mark Study and continue to be ongoing with the HeartMate 3 LVAS after the CE Mark Study 2 year follow-up will be enrolled in this study.
Who may be able to join
- Patient or legal representative has signed Informed Consent Form (ICF).
- 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.
Who cannot join
- 1. Patient does not consent to the continued data collection.
Trial locations and contacts
8 sites in 6 countries.
8 sites in 6 countries
Germany3 sites
Deutsches Herzzentrum Berlin
Berlin, 13353
Universitats-Herzzentrum Freiburg
Freiburg im Breisgau, 79106
Medizinische Hochschule Hannover
Hanover, 30625
Czechia1 site
Institute for Clinical and Experimental Medicine (IKEM)
Prague, 4
Kazakhstan1 site
National Research Center for Cardiac Surgery
Astana, 010000
About this study
Official title: HeartMate 3 CE Mark Study Long Term Follow-up Clinical Investigation Plan
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.
- Being tested
- Long term follow-up
- Keywords
- Heart Failure, Ventricular Dysfunction, Cardiomyopathies, Heart Disease, Cardiovascular Disease, Heart-assist Devices, Thoratec Corporation
- Medical subject headings
- Heart Failure, Ventricular Dysfunction, Cardiomyopathies, Heart Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long term follow-upOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Long term follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Subject outcomes and survival over time
Measured: At 5 years post HM3 CE Mark study implant
Secondary outcomes (8)
EuroQoL 5D-5L (EQ-5D-5L) VAS Score
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
Measured: At 5 years post HM3 CE Mark study implant
Six Minute Walk Test (6MWT)
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
Measured: At 5 years post HM3 CE Mark study implant
New York Heart Association (NYHA)
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.
Measured: At 5 years post HM3 CE Mark study implant
Adverse Events
Number of Participants with Adverse Events
Measured: Between 2 and 5 years post HM3 CE Mark study implant
Device Malfunctions
Number of Participants with device malfunctions
Measured: Between 2 and 5 years post HM3 CE Mark study implant
Reoperations
Number of reoperations
Measured: Between 2 and 5 years post HM3 CE Mark study implant
Rehospitalizations
Number of rehospitalizations
Measured: Between 2 and 5 years post HM3 CE Mark study implant
Percentage of Participants Who Survived Without Experiencing a Debilitating Stroke (MRS>3)
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
Measured: As it may occur up to 5 years post HM3 CE Mark study implant or to outcome, whichever occurs first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2017 (estimated)
- Study start23 Jun 2014
- Primary completion12 Dec 2019
- Study completion12 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced Refractory Left Ventricular Heart FailureStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carlo Gazzola, B. Sc., Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03022461
- Sponsor's protocol ID
- HeartMate 3 CE Mark Study LTFU
- Acronym
- HM3 CE LTFU
- Status last verified
- Jun 2022
- First submitted
- 12 Jan 2017
- Last updated
- 27 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HeartMate 3 CE Mark Study Long Term Follow-up Clinical Investigation Plan
- ClinicalTrials.gov ID
- NCT03022461
- Acronym / sponsor ID
- HM3 CE LTFU / HeartMate 3 CE Mark Study LTFU
- Keywords
- Heart Failure, Ventricular Dysfunction, Cardiomyopathies, Heart Disease, Cardiovascular Disease, Heart-assist Devices, Thoratec Corporation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 23 Jun 2014 (actual)
- Primary completion
- 12 Dec 2019 (actual)
- Study completion
- 12 Dec 2019 (actual)
- First posted
- 16 Jan 2017 (estimated)
- Results
- Posted 2 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ongoing HM3 CE Mark study patients | – | Other: Long term follow-upThe study will include the ongoing HM3 CE Mark study patients that have consented to continue the long term follow-up data collection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced refractory left ventricular heart failure who were implanted with HeartMate 3 in the CE Mark Study and continue to be ongoing with the HeartMate 3 LVAS after the CE Mark Study 2 year follow-up will be enrolled in this study.
Key inclusion criteria (2 listed)
- Patient or legal representative has signed Informed Consent Form (ICF).
- 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.
Key exclusion criteria (1 listed)
- 1. Patient does not consent to the continued data collection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Long term follow-up | Other | Ongoing HM3 CE Mark study patients |
Primary outcome
Survival
Time frame: At 5 years post HM3 CE Mark study implant
Subject outcomes and survival over time
8 secondary outcomes
EuroQoL 5D-5L (EQ-5D-5L) VAS Score
Time frame: At 5 years post HM3 CE Mark study implant
Six Minute Walk Test (6MWT)
Time frame: At 5 years post HM3 CE Mark study implant
New York Heart Association (NYHA)
Time frame: At 5 years post HM3 CE Mark study implant
Adverse Events
Time frame: Between 2 and 5 years post HM3 CE Mark study implant
Device Malfunctions
Time frame: Between 2 and 5 years post HM3 CE Mark study implant
Reoperations
Time frame: Between 2 and 5 years post HM3 CE Mark study implant
Rehospitalizations
Time frame: Between 2 and 5 years post HM3 CE Mark study implant
Percentage of Participants Who Survived Without Experiencing a Debilitating Stroke (MRS>3)
Time frame: As it may occur up to 5 years post HM3 CE Mark study implant or to outcome, whichever occurs first
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Recruiting
Corheart 6 LVAS Study
Refractory Heart Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlo Gazzola, B. Sc. study director
Abbott
8 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Refractory Left Ventricular Heart Failure, run by Abbott Medical Devices at 8 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany, Australia, Austria, Canada, Czechia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: At 5 years post HM3 CE Mark study implant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2022.