Heart FailureNCT01831544
A Clinical Trial to Evaluate the HeartWare MVAD® System (MVAdvantage)
A study testing HeartWare MVAD® System in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 11 sites in 5 countries.
Trial summary
This multi-center, prospective, non-randomized, single-arm trial will investigate the safety and performance of the HeartWare® Miniaturized Ventricular Assist Device (MVAD®) system over 24 months in subjects with advanced heart failure Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- HeartWare MVAD® System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 11 sitesin 5 countries
- Study dates
- 14 Jul 2015to 16 Feb 2017
- 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
- Must be ≥18 years of age at consent
- Subjects with advanced heart failure symptoms (Class IIIB or IV) who meet one of the following):
- on optimal medical management including dietary salt restriction and diuretics, for at least 45 out of the last 60 days and are failing to respond; or
- in Class III or Class IV heart failure for at least 14 days and dependent on intra-aortic balloon pump (IABP) and/or inotropes.
- Left ventricular ejection fraction ≤25%.
- Female subjects of childbearing potential must agree to use adequate contraceptive precautions (defined as oral contraceptives, intrauterine devices, surgical contraceptives or a combination of condom and spermicide) for the duration of the study.
- The subject has signed the informed consent form.
Who cannot join
- Body Mass Index (BMI) > 47.
- Body Surface Area (BSA) < 1.0 m2.
- Partial or full mechanical circulatory support within thirty days of implant.
- Existence of any ongoing mechanical circulatory support (MCS) other than an intra-aortic balloon pump (IABP) or TandemHeart PTVA®.
- Prior cardiac transplant or cardiomyoplasty.
- History of confirmed, untreated abdominal or thoracic aortic aneurysm (diameter > 5 cm).
Show all 30Show fewer
- Acute myocardial infarction within 14 days of implant as diagnosed by ST or T wave changes on the electrocardiogram (ECG), diagnostic biomarkers, ongoing pain and hemodynamic abnormalities.
- On ventilator support for > 72 hours within the four days immediately prior to implant.
- Pulmonary embolus within three weeks of implant as documented by computed tomography (CT) scan or nuclear scan.
- Symptomatic cerebrovascular disease, stroke within 180 days of implant or > 80% stenosis of carotid or cranial vessels in the absence of confirmed collateral circulation
- Uncorrected moderate to severe aortic insufficiency.
- Severe right ventricular failure as defined by the anticipated need for extracorporeal membrane oxygenation (ECMO) at the time of screening.
- Active, uncontrolled infection diagnosed by a combination of clinical symptoms and laboratory testing, including but not limited to, continued positive cultures, elevated temperature and white blood cell (WBC) count, hypotension, tachycardia, generalized malaise despite appropriate antibiotic, antiviral or antifungal treatment.
- Uncorrected thrombocytopenia or generalized coagulopathy (e.g., platelet count < 75,000, International Normalized Ratio (INR) > 2.0 or Partial Thromboplastin Time (PTT) > 2.5 times control in the absence of anticoagulation therapy).
- Intolerance to anticoagulant or antiplatelet therapies or any other peri- or postoperative therapy that the investigator may administer based upon the subject's health status.
- Serum creatinine > 3.0 mg/dL within 72 hours of implant or requiring dialysis.
- Specific liver enzymes [Aspartate Aminotransferase (AST) (SGOT), and Alanine Aminotransferase (ALT) (SGPT)] > 3 times upper limit of normal within 72 hours of implant.
- A total bilirubin > 3 mg/dL within 72 hours of implant, or biopsy proven liver cirrhosis or portal hypertension.
- Pulmonary vascular resistance (PVR) is demonstrated to be unresponsive to pharmacological manipulation.
- Subjects with a mechanical heart valve.
- Etiology of heart failure is due to, or associated with, uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, active myocarditis or restrictive cardiomyopathy.
- History of severe COPD or severe restrictive lung disease (e.g. FEV1 < 50% predicted value).
- Participation in any other trial involving investigational drugs or devices within 4 weeks prior to screening and last visit of the trial.
- Severe illness, other than heart disease, which would limit survival to < 3 years.
- Peripheral vascular disease with rest pain or ischemic ulcers of the extremities.
- Pregnancy and breast feeding.
- Psychiatric disease, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the CIP and LVAD.
- Subject unwilling or unable to comply with trial requirements.
- Technical obstacles, which pose an inordinately high surgical risk, in the judgment of the investigator.
- Employees of the investigator or trial site, with direct involvement in this trial or other trials under the direction of the investigator or trial site, as well as family members or employees of the investigator.
Trial locations and contacts
11 sites in 5 countries.
11 sites in 5 countries
Germany6 sites
The Heart and Diabetes Center NRW
Bad Oeynhausen, 32545
German Heart Institute Berlin DHZB
Berlin, 13353
Duesseldorf University Hospital
Düsseldorf, 40225
Uniklinik Hamburg Eppendorf (UKE)
Hamburg, 20245
Hannover Medical School MHH
Hanover, 30625
University of Leipzig Heart Center
Leipzig, 04289
United Kingdom2 sites
Freeman Hospital
Newcastle upon Tyne, NE77DN
Papworth Hospital NHS Foundation
Papworth Everard, CB233RE
About this study
Official title: Multi Center, Prospective, Non-Randomized, Single-Arm Trial Evaluating the Clinical Safety and Performance Of the HeartWare MVAD® System For the Treatment of Advanced Heart Failure
This multi-center, prospective, non-randomized, single-arm trial will investigate the safety and performance of the HeartWare® Miniaturized Ventricular Assist Device (MVAD®) system over 24 months in subjects with advanced heart failure
Read the detailed description
This multi-center, prospective, non-randomized, single-arm trial will investigate the safety and performance of the Miniaturized Ventricular Assist Device (MVAD®) system over 24 months in subjects with advanced heart failure. The primary endpoint is survival at 6 months presented as a simple proportion (subjects alive on the MVAD® pump divided by endpoint eligible subjects). Secondary endpoints include the incidence of bleeding, incidence of major infections (per INTERMACS definitions), time to death, incidence of all device failures and device malfunctions, Health Status improvement, and Functional status improvement. Safety measures will include the frequency and rates of adverse events, overall and for each specific event, which will be collected throughout VAD support.
- Conditions
- Heart Failure
- Being tested
- HeartWare MVAD® System
- Keywords
- Heart Failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeartWare MVAD® SystemDevice
The HeartWare MVAD® System consists of a small, wearless, continuous flow pump and associated surgical tools and implant accessories, peripheral components which control and power the system, and a monitor which allows for programming and monitoring of the system
| Study group | Role | What they receive |
|---|---|---|
| MVAD® Pump | Experimental | Implant of HeartWare MVAD® System Receives: Device: HeartWare MVAD® System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Primary Endpoint: survival at 6 months presented as a simple proportion. Transplants, explants for recovery and exchanges (to a device other than the MVAD® pump) prior to 6 month follow-up will be eligible for endpoint analysis, with survival status identified at the time of procedure.
Measured: Six month
Secondary outcomes (15)
Survival
Survival at 24 months presented as a simple proportion. Transplants, explants for recovery and exchanges (to a device other than the MVAD® pump) prior to 24 month follow-up will be eligible for endpoint analysis, with survival status identified at the time of procedure.
Measured: Two years
Survival: Number of Participants Who Died by Six Months and Two Years
Survival: Number of participants who died by six months and two years
Measured: Six months and two years
Incidence of Major Bleeding
Incidence of major bleeding, per INTERMACS definition
Measured: Six months and two years
Incidence of All Device Failures and Device Malfunctions
Incidence of all device failures and device malfunctions per INTERMACS definition
Measured: Six months and two years
Incidence of Major Infection
Incidence of major infection, per INTERMACS definition
Measured: Six months and two years
Incidence of Neurological Dysfunction
Incidence of neurological dysfunction per INTERMACS definition
Measured: Six months and two years
Health Status Change, as Measured by KCCQ and EuroQol EQ-5D-5L
Health Status change, as measured by KCCQ and EuroQol EQ-5D-5L. Measured at baseline, 6 month visit and 24 month visit. Change from baseline at 6 month visit and 24 month visit were measured. The EQ-5D-5L overall score is between 0 and 1. 1 being the best score and 0 being the worst score. The KCCQ score is between 0 and 100. 100 being the best score and 0 being the worst score.
Measured: Six month and 24 month visit
Functional Status Change, as Measured 6-minute Walk
Functional status change, as measured by 6-minute walk. Distance walked in meters in 6 minutes measured at baseline, 6 months and 24 month visit. Change from baseline at 6 month visit and 24 month visit were measured
Measured: 6 month and 24 month visit
Frequency and Rates of Adverse Events(AEs)
Frequency and rates of adverse events(AEs) throughout VAD support per INTERMACS Definition
Measured: Six months and two years
Length of Initial Hospital Stay (Days)
Length of Initial hospital stay (days) from procedure start to discharge
Measured: Post operation
Re-Hospitalizations
The length of Re-Hospitalization, excluding planned procedures, stay in days.
Measured: On or before 6 months follow-up and 24 month follow-up
Transplantations
Transplantations of subjects enrolled in study and implanted with MVAD System
Measured: Six months and two years
Explants
Explants (i.e. death, transplant, recovery, device exchange) of MVAD in subjects enrolled in study and implanted with MVAD System
Measured: Six months and two years
New York Heart Association (NYHA) Functional Classification Score
NYHA score measured at baseline, 6 month visit and 24 month visit. The NYHA scale is from I to IV. A subject with a score of IV indicates more severe heart failure than a subject with a score of I.
Class I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath Class II: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain Class III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain Class IV: Symptoms of heart failure at rest. Any physical activity causes further discomfort
Measured: Baseline and 6 month and 24 month visit
Length of Operative Time (Hours)
Length of operative time (hours)
Measured: Implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2013 (estimated)
- Study start14 Jul 2015
- Primary completion1 Sep 2015
- Study completion16 Feb 2017
Why it stopped: Recruitment terminated due to higher rate of thrombosis events than expected.
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 Heart FailureStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Rhythm and Heart FailureThe 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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephan Schueler, Principal investigator, Freeman Hospital Newcastle Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01831544
- Sponsor's protocol ID
- HW-MVAD-01
- Status last verified
- Jul 2022
- First submitted
- 8 Apr 2013
- Last updated
- 23 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi Center, Prospective, Non-Randomized, Single-Arm Trial Evaluating the Clinical Safety and Performance Of the HeartWare MVAD® System For the Treatment of Advanced Heart Failure
- ClinicalTrials.gov ID
- NCT01831544
- Acronym / sponsor ID
- HW-MVAD-01
- Conditions
- Heart Failure
- Keywords
- Heart Failure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment terminated due to higher rate of thrombosis events than expected.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- 14 Jul 2015 (actual)
- Primary completion
- 1 Sep 2015 (actual)
- Study completion
- 16 Feb 2017 (actual)
- First posted
- 15 Apr 2013 (estimated)
- Results
- Posted 7 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multi-center, prospective, non-randomized, single-arm trial will investigate the safety and performance of the HeartWare® Miniaturized Ventricular Assist Device (MVAD®) system over 24 months in subjects with advanced heart failure
Detailed description
This multi-center, prospective, non-randomized, single-arm trial will investigate the safety and performance of the Miniaturized Ventricular Assist Device (MVAD®) system over 24 months in subjects with advanced heart failure. The primary endpoint is survival at 6 months presented as a simple proportion (subjects alive on the MVAD® pump divided by endpoint eligible subjects). Secondary endpoints include the incidence of bleeding, incidence of major infections (per INTERMACS definitions), time to death, incidence of all device failures and device malfunctions, Health Status improvement, and Functional status improvement. Safety measures will include the frequency and rates of adverse events, overall and for each specific event, which will be collected throughout VAD support.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MVAD® Pump | Experimental | Device: HeartWare MVAD® SystemImplant of HeartWare MVAD® System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Must be ≥18 years of age at consent
- Subjects with advanced heart failure symptoms (Class IIIB or IV) who meet one of the following):
- Left ventricular ejection fraction ≤25%.
- Female subjects of childbearing potential must agree to use adequate contraceptive precautions (defined as oral contraceptives, intrauterine devices, surgical contraceptives or a combination of condom and spermicide) for the duration of the study.
- The subject has signed the informed consent form.
Key exclusion criteria (30 listed)
- Body Mass Index (BMI) > 47.
- Body Surface Area (BSA) < 1.0 m2.
- Partial or full mechanical circulatory support within thirty days of implant.
- Existence of any ongoing mechanical circulatory support (MCS) other than an intra-aortic balloon pump (IABP) or TandemHeart PTVA®.
- Prior cardiac transplant or cardiomyoplasty.
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 |
|---|---|---|
| HeartWare MVAD® SystemThe HeartWare MVAD® System consists of a small, wearless, continuous flow pump and associated surgical tools and implant accessories, peripheral components which control and power the system, and a monitor which allows for programming and monitoring of the system | Device | MVAD® Pump |
Primary outcome
Survival
Time frame: Six month
Primary Endpoint: survival at 6 months presented as a simple proportion. Transplants, explants for recovery and exchanges (to a device other than the MVAD® pump) prior to 6 month follow-up will be eligible for endpoint analysis, with survival status identified at the time of procedure.
15 secondary outcomes
Survival
Time frame: Two years
Survival: Number of Participants Who Died by Six Months and Two Years
Time frame: Six months and two years
Incidence of Major Bleeding
Time frame: Six months and two years
Incidence of All Device Failures and Device Malfunctions
Time frame: Six months and two years
Incidence of Major Infection
Time frame: Six months and two years
Incidence of Neurological Dysfunction
Time frame: Six months and two years
Health Status Change, as Measured by KCCQ and EuroQol EQ-5D-5L
Time frame: Six month and 24 month visit
Functional Status Change, as Measured 6-minute Walk
Time frame: 6 month and 24 month visit
Frequency and Rates of Adverse Events(AEs)
Time frame: Six months and two years
Length of Initial Hospital Stay (Days)
Time frame: Post operation
Re-Hospitalizations
Time frame: On or before 6 months follow-up and 24 month follow-up
Transplantations
Time frame: Six months and two years
Explants
Time frame: Six months and two years
New York Heart Association (NYHA) Functional Classification Score
Time frame: Baseline and 6 month and 24 month visit
Length of Operative Time (Hours)
Time frame: Implant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Stephan Schueler principal investigator
Freeman Hospital Newcastle Hospitals NHS Foundation Trust
11 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HeartWare MVAD® System in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 11 sites in 5 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 7 inclusion and 30 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: stopped early, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Germany, United Kingdom, Australia, Austria, France. 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 7 Apr 2020). 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: Six month). 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 23 Sep 2025.