Advanced Refractory Left Ventricular Heart FailureHM3 CE MarkNCT02170363
HeartMate 3™ CE Mark Clinical Investigation Plan
A study testing Left Ventricular Assist System (LVAS) in people with Advanced Refractory Left Ventricular Heart Failure, run by Abbott Medical Devices at 10 sites in 6 countries.
Trial summary
The purpose of this clinical investigation is to evaluate the performance and safety of the HeartMate 3 Left Ventricular Assist System (HM3 LVAS) To support obtaining CE Mark for the HM3 LVAS in Europe, a multi-center clinical study will be conducted in multiple countries. 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?
- Left Ventricular Assist System (LVAS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 10 sitesin 6 countries
- Study dates
- Jun 2014to 9 Mar 2020
- Phase
- Interventional
- 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
Who may be able to join
- Patient or legal representative has signed Informed Consent Form (ICF)
- Age ≥ 18 years
- BSA ≥ 1.2 m2
- NYHA IIIB or IV OR ACC/AHA Stage D
- LVEF ≤ 25%
- CI ≤ 2.2 L/min/m2, while not on inotropes
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- Patients must also meet one of the following:
- On Optimal Medical Management (OMM), based on current heart failure practice guidelines for at least 45 out of the last 60 days and are failing to respond,
- OR
- In NYHA class IIIB or IV heart failure for at least 14 days AND dependent on intraaortic balloon pump (IABP) for at least 7 days,
- OR
- Inotrope dependent/unable to wean from inotropes
- OR
- Listed for Transplant
- Females of child bearing age must agree to use adequate contraception
Who cannot join
- Etiology of HF due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis or restrictive cardiomyopathy
- Technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator
- Existence of ongoing mechanical circulatory support (MCS) other than IABP
- Positive pregnancy test if of childbearing potential
- Lactating mothers
- Presence of mechanical aortic cardiac valve that will not be converted to a bioprosthesis at the time of LVAD implant
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- History of any organ transplant
- Platelet count < 100,000 x 103/L (< 100,000/ml)
- Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and LVAS management
- History of confirmed, untreated AAA > 5 cm in diameter
- Presence of an active, uncontrolled infection
- Intolerance to anticoagulant or antiplatelet therapies or any other peri/post-operative therapy the investigator will require based upon the patients' health status
- Presence of any one of the following risk factors for indications of severe end organ dysfunction or failure:
- An INR ≥ 2.5 not due to anticoagulation therapy
- Total bilirubin > 43 umol/L (2.5 mg/dl), shock liver, or biopsy proven liver cirrhosis
- History of severe chronic obstructive pulmonary disease (COPD) defined by FEV1/FVC < 0.7, or FEV1 <50% predicted
- Fixed pulmonary hypertension with a most recent PVR ≥ 8 Wood units that is unresponsive to pharmacologic intervention
- History of stroke within 90 days prior to enrollment, or a history of cerebrovascular disease with significant (> 80%) carotid artery stenosis
- Serum creatinine ≥221umol/L (2.5 mg/dl) or the need for chronic renal replacement therapy
- Significant peripheral vascular disease (PVD) accompanied by rest pain or extremity ulceration
- Patient has moderate to severe aortic insufficiency without plans for correction during pump implant
- Pre albumin < 150 mg/L, or Albumin < 30g/L (3 g/dL)
- Planned Bi-VAD support prior to enrollment
- Patient has known hypo or hyper coagulable states such as disseminated intravascular coagulation and heparin induced thrombocytopenia
- Participation in any other clinical investigation that is likely to confound study results or affect the study
- Any condition other than HF that could limit survival to less than 24 months
Trial locations and contacts
10 sites in 6 countries.
10 sites in 6 countries
Germany5 sites
Herz- und Diabeteszentrum NRW Thorax- und Kardiovaskularchirurgie Clinic
Bad Oeynhausen, 32545
Deutsches Herzzentrum Berlin
Berlin, 13353
Universitats-Herzzentrum Freiburg
Freiburg im Breisgau, 79106
Medizinische Hochschule Hannover
Hanover, 30625
Herzentrum Leipzig GmbH
Leipzig, 04280
Czechia1 site
Institute for Clinical and Experimental Medicine (IKEM)
Prague, 4
Kazakhstan1 site
National Research Center for Cardiac Surgery
Astana, 010000
About this study
The purpose of this clinical investigation is to evaluate the performance and safety of the HeartMate 3 Left Ventricular Assist System (HM3 LVAS) To support obtaining CE Mark for the HM3 LVAS in Europe, a multi-center clinical study will be conducted in multiple countries. The clinical study will be conducted in compliance with the Declaration of Helsinki, ICH/GCP and EN ISO 14155:2011 Requirements for Clinical Investigations and in accordance with country-specific requirements, under one clinical study protocol.
This study will evaluate the performance of the HM3 LVAS, side effects and undesirable conditions within acceptable risks and weigh them against the intended performance of HM3 LVAS in accordance with Essential Requirements 2, 5 and 16 of the Active Implantable Medical Device Directive 90/385/EEC (AIMDD).
- Being tested
- Left Ventricular Assist System (LVAS)
- 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.
Left Ventricular Assist System (LVAS)Device
Implantation of left ventricular assist device for hemodynamic support
| Study group | Role | What they receive |
|---|---|---|
| HeartMate 3 | Experimental | Left Ventricular Assist System (LVAS) to be used on Subjects with advanced refractory left ventricular heart failure Receives: Device: Left Ventricular Assist System (LVAS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Comparison of survival at 6 months of Left Ventricular Assist Device (LVAD) support to a performance goal established using matched HeartMate II INTERMACS data
Measured: 6 months
Secondary outcomes (8)
Quality of Life (EQ-5D-5L)
The EQ-5D-5L is a standardized measure of health status developed by the EuroQol Group. Patients describe their perceived health status using an analog scale with 0 as the worst health the patient can imagine and 100 as the best health (Visual Analog Score). The patients' scores at one, three and six months were compared to their baseline scores and the resulting positive scores indicated improved quality of life.
Measured: Baseline, Month 1, Month 3, Month 6
Functional Status - 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.
Measured: Baseline, Month 1, Month 3, Month 6
Functional Status - New York Heart Association (NYHA) Classification
NYHA classification 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
Measured: Baseline, Month 1, Month 3, Month 6
All Adverse Events
Frequency of pre-defined anticipated adverse events
Measured: As they occurred, Baseline through 180 Days
Device Malfunctions
Frequency and incidence of device malfunction
Measured: As they occurred, Baseline through 180 Days; Subjects that remain ongoing after 6 months will continue to be followed to 24 months post-implant or outcome
Reoperations
Frequency of reoperations
Measured: As they occurred, Baseline through 180 Days
Rehospitalizations
Frequency and incidence of rehospitalizations
Measured: As they occurred, Baseline through 180 Days
Stroke Free Survival
Percentage of participants free of debilitating stroke (Modified Rankin Score > 3)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionMay 2015
- Study completion9 Mar 2020
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.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Center for Life Sciences, Emergo, KCRI, Thoratec Corporation
- Responsible party
- Sponsor
- Investigators
- Carlo Gazzola, B. Sc., Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02170363
- Sponsor's protocol ID
- TC02212014
- Acronym
- HM3 CE Mark
- Status last verified
- Jun 2022
- First submitted
- 19 Jun 2014
- Last updated
- 27 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Netuka I, Sood P, Pya Y, Zimpfer D, Krabatsch T, Garbade J, Rao V, Morshuis M, Marasco S, Beyersdorf F, Damme L, Schmitto JD. Fully Magnetically Levitated Left Ventricular Assist System for Treating Advanced HF: A Multicenter Study. J Am Coll Cardiol. 2015 Dec 15;66(23):2579-2589. doi: 10.1016/j.jacc.2015.09.083.
PubMed 26670056Schmitto JD, Pya Y, Zimpfer D, Krabatsch T, Garbade J, Rao V, Morshuis M, Beyersdorf F, Marasco S, Sood P, Damme L, Netuka I. Long-term evaluation of a fully magnetically levitated circulatory support device for advanced heart failure-two-year results from the HeartMate 3 CE Mark Study. Eur J Heart Fail. 2019 Jan;21(1):90-97. doi: 10.1002/ejhf.1284. Epub 2018 Jul 27.
PubMed 30052304Krabatsch T, Netuka I, Schmitto JD, Zimpfer D, Garbade J, Rao V, Morshuis M, Beyersdorf F, Marasco S, Damme L, Pya Y. Heartmate 3 fully magnetically levitated left ventricular assist device for the treatment of advanced heart failure -1 year results from the Ce mark trial. J Cardiothorac Surg. 2017 Apr 4;12(1):23. doi: 10.1186/s13019-017-0587-3.
PubMed 28376837
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 Clinical Investigation Plan
- ClinicalTrials.gov ID
- NCT02170363
- Acronym / sponsor ID
- HM3 CE Mark / TC02212014
- Keywords
- Heart Failure, Ventricular Dysfunction, Cardiomyopathies, Heart Disease, Cardiovascular Disease, Heart-assist devices, Thoratec Corporation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Collaborators
- Center for Life Sciences, Emergo, KCRI, Thoratec Corporation
- Study start
- Jun 2014
- Primary completion
- May 2015 (actual)
- Study completion
- 9 Mar 2020 (actual)
- First posted
- 23 Jun 2014 (estimated)
- Results
- Posted 15 Feb 2018
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 evaluate the performance and safety of the HeartMate 3 Left Ventricular Assist System (HM3 LVAS) To support obtaining CE Mark for the HM3 LVAS in Europe, a multi-center clinical study will be conducted in multiple countries. The clinical study will be conducted in compliance with the Declaration of Helsinki, ICH/GCP and EN ISO 14155:2011 Requirements for Clinical Investigations and in accordance with country-specific requirements, under one clinical study protocol.
This study will evaluate the performance of the HM3 LVAS, side effects and undesirable conditions within acceptable risks and weigh them against the intended performance of HM3 LVAS in accordance with Essential Requirements 2, 5 and 16 of the Active Implantable Medical Device Directive 90/385/EEC (AIMDD).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HeartMate 3 | Experimental | Device: Left Ventricular Assist System (LVAS)Left Ventricular Assist System (LVAS) to be used on Subjects with advanced refractory left ventricular heart failure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patient or legal representative has signed Informed Consent Form (ICF)
- Age ≥ 18 years
- BSA ≥ 1.2 m2
- NYHA IIIB or IV OR ACC/AHA Stage D
- LVEF ≤ 25%
Key exclusion criteria (26 listed)
- Etiology of HF due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis or restrictive cardiomyopathy
- Technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator
- Existence of ongoing mechanical circulatory support (MCS) other than IABP
- Positive pregnancy test if of childbearing potential
- Lactating mothers
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 |
|---|---|---|
| Left Ventricular Assist System (LVAS)Implantation of left ventricular assist device for hemodynamic support | Device | HeartMate 3 |
Primary outcome
Survival
Time frame: 6 months
Comparison of survival at 6 months of Left Ventricular Assist Device (LVAD) support to a performance goal established using matched HeartMate II INTERMACS data
8 secondary outcomes
Quality of Life (EQ-5D-5L)
Time frame: Baseline, Month 1, Month 3, Month 6
Functional Status - Six Minute Walk Test (6MWT)
Time frame: Baseline, Month 1, Month 3, Month 6
Functional Status - New York Heart Association (NYHA) Classification
Time frame: Baseline, Month 1, Month 3, Month 6
All Adverse Events
Time frame: As they occurred, Baseline through 180 Days
Device Malfunctions
Time frame: As they occurred, Baseline through 180 Days; Subjects that remain ongoing after 6 months will continue to be followed to 24 months post-implant or outcome
Reoperations
Time frame: As they occurred, Baseline through 180 Days
Rehospitalizations
Time frame: As they occurred, Baseline through 180 Days
Stroke Free Survival
Time frame: 6 months
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.
- Results publication: PubMed 26670056Netuka I, Sood P, Pya Y, Zimpfer D, Krabatsch T, Garbade J, Rao V, Morshuis M, Marasco S, Beyersdorf F, Damme L, Schmitto JD. Fully Magnetically Levitated Left Ventricular Assist System for Treating Advanced HF: A Multicenter Study. J Am Coll Cardiol. 2015 Dec 15;66(23):2579-2589. doi: 10.1016/j.jacc.2015.09.083.
- Derived from this study: PubMed 30052304Schmitto JD, Pya Y, Zimpfer D, Krabatsch T, Garbade J, Rao V, Morshuis M, Beyersdorf F, Marasco S, Sood P, Damme L, Netuka I. Long-term evaluation of a fully magnetically levitated circulatory support device for advanced heart failure-two-year results from the HeartMate 3 CE Mark Study. Eur J Heart Fail. 2019 Jan;21(1):90-97. doi: 10.1002/ejhf.1284. Epub 2018 Jul 27.
- Derived from this study: PubMed 28376837Krabatsch T, Netuka I, Schmitto JD, Zimpfer D, Garbade J, Rao V, Morshuis M, Beyersdorf F, Marasco S, Damme L, Pya Y. Heartmate 3 fully magnetically levitated left ventricular assist device for the treatment of advanced heart failure -1 year results from the Ce mark trial. J Cardiothorac Surg. 2017 Apr 4;12(1):23. doi: 10.1186/s13019-017-0587-3.
Related trials for Advanced Refractory Left Ventricular Heart Failure
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European Study of the BrioVAD Heart Pump for Advanced Heart Failure
Refractory Heart Failure, Cardiovascular Diseases (CVD)
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
10 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Left Ventricular Assist System (LVAS) in people with Advanced Refractory Left Ventricular Heart Failure, run by Abbott Medical Devices at 10 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 15 inclusion and 26 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 10 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 15 Feb 2018). 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: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02170363, which also lists 3 linked publications.
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.