Heart FailureHM 3 LISNCT02475460
HeartMate 3™ LIS Study
A study testing Less Invasive Surgery (LIS) and HeartMate 3™ in people with Heart Failure and Cardiovascular Disease, run by Abbott Medical Devices at 3 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate a less invasive implantation technique of the HeartMate 3 Left Ventricular Assist System (HM 3 LVAS) in 10 patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Cardiovascular Disease
- What is being tested?
- Less Invasive Surgery (LIS) and HeartMate 3™
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 3 sitesin 2 countries
- Study dates
- May 2015to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 (if Patient is treated with inotropes at baseline, this does not apply)
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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 heart failure (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
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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 that 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
- Aortic valve regurgitation > grade 1
- 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
- Planned concomitant intra-cardiac cardiac surgery
- Thrombus formation in the atrium or left ventricle identified by echocardiogram
- Previous sternotomy or left-sided thoracotomy
- 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 6 months
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Germany2 sites
Deutsches Herzzentrum Berlin
Berlin, 13353
Medizinische Hochschule Hannover
Hanover, 30625
Czechia1 site
Institute for Clinical and Experimental Medicine (IKEM)
Prague, 4
About this study
Official title: Thoratec Corporation HeartMate 3™ Less Invasive Surgery (LIS) Study
The purpose of this study is to evaluate a less invasive implantation technique of the HeartMate 3 Left Ventricular Assist System (HM 3 LVAS) in 10 patients.
Read the detailed description
This study will evaluate the less invasive implantation technique of the HM 3 LVAS.
- Conditions
- Heart Failure, Cardiovascular Disease
- Being tested
- Less Invasive Surgery (LIS), HeartMate 3™
- Keywords
- HeartMate 3, LVAS, LVAD, Heart-assist Devices, Advanced, Ventricular Dysfunction, refractory left ventricular, Thoratec Corporation
- Medical subject headings
- Heart Failure, Cardiovascular Diseases, Ventricular Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Less Invasive Surgery (LIS)Procedure or surgery
Less invasive HM 3 LVAD surgical implant procedure
HeartMate 3™Device
HM 3 LIS
| Study group | Role | What they receive |
|---|---|---|
| HM 3 LIS | Experimental | All patients implanted with the HM 3 LVAD via less invasive surgical technique Receives: Procedure: Less Invasive Surgery (LIS); Device: HeartMate 3™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of survival participants
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2015 (estimated)
- Study startMay 2015
- Primary completionJan 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Thoratec Corporation
- Responsible party
- Sponsor
- Investigators
- Sami Somo, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02475460
- Sponsor's protocol ID
- HeartMate 3 LIS
- Acronym
- HM 3 LIS
- Status last verified
- Jun 2022
- First submitted
- 11 Jun 2015
- Last updated
- 24 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoratec Corporation HeartMate 3™ Less Invasive Surgery (LIS) Study
- ClinicalTrials.gov ID
- NCT02475460
- Acronym / sponsor ID
- HM 3 LIS / HeartMate 3 LIS
- Conditions
- Heart Failure, Cardiovascular Disease
- Keywords
- HeartMate 3, LVAS, LVAD, Heart-assist Devices, Advanced, Ventricular Dysfunction, refractory left ventricular, Thoratec Corporation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Collaborators
- Thoratec Corporation
- Study start
- May 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 18 Jun 2015 (estimated)
- Results
- Not posted in the source record
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 study is to evaluate a less invasive implantation technique of the HeartMate 3 Left Ventricular Assist System (HM 3 LVAS) in 10 patients.
Detailed description
This study will evaluate the less invasive implantation technique of the HM 3 LVAS.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HM 3 LIS | Experimental | Procedure: Less Invasive Surgery (LIS), Device: HeartMate 3™All patients implanted with the HM 3 LVAD via less invasive surgical technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 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 (29 listed)
- Etiology of heart failure (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 |
|---|---|---|
| Less Invasive Surgery (LIS)Less invasive HM 3 LVAD surgical implant procedure | Procedure or surgery | HM 3 LIS |
| HeartMate 3™HM 3 LIS | Device | HM 3 LIS |
Primary outcome
Number of survival participants
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2022.
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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.
Sami Somo study director
Abbott
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Less Invasive Surgery (LIS) and HeartMate 3™ in people with Heart Failure and Cardiovascular Disease, run by Abbott Medical Devices at 3 sites in 2 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 12 inclusion and 29 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 24 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 3 sites in Germany, Czechia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of survival participants (time frame: 30 days). 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 24 Jun 2022.