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End-stage Heart FailureSweVADNCT02592499

Swedish Evaluation of Left Ventricular Assist Device as Permanent Treatment in End-stage Heart Failure

A study testing HM III and OMM, optimal medical management in people with End-stage Heart Failure, run by Vastra Gotaland Region at 7 sites in Sweden.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The study is a prospective, randomized, non-blinded, national, multi-center study. The study will consist of the assignment of eligible patients to treatment with either a HeartMate III (HM III) left ventricular assist device system or to pharmacological treatment (optimal medical management, OMM) according to current… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
End-stage Heart Failure
What is being tested?
HM III and OMM, optimal medical management
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
7 sitesSweden
Study dates
Jun 2016to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • Signed informed consent
  • Adult (≥ 18 years)
  • Chronic heart failure ≥ 45 days or stable not supported by mechanical circulatory support since >7days on single inotrope.
  • Left ventricular ejection fraction ≤ 30%.
  • NYHA IIIB-IV, INTERMACS profile 2-6
  • At least 2 of 4 adverse prognostic criteria:
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  • SHFM estimated 1-year survival ≤75%
  • NTproBNP ≥ 2000 ng/l
  • VO2 max < 14 ml/kg/min or <50% of predicted VO2max with attainment of anaerobic threshold (AT), or unable to perform.
  • Need for continuous or intermittent inotropic support or >2 hospitalizations during last 6 months.
  • Receiving medical management with optimal doses of betablockers, ACE-inhibitors or ARBs, and MRAs for at least 30 days if tolerated.
  • Receiving CRT if indicated for at least 45 days.
  • Receiving ICD if indicated and appropriate.
  • Ineligible for cardiac transplantation (e.g. high age and/or co-morbidities)
  • Considered suitable for the study by a multidisciplinary board

Who cannot join

  • Eligible for heart transplantation or is likely to become eligible after VAD treatment (bridge-to-candidacy)
  • Indication for revascularisation, valvular surgery or other cardiac intervention expected to improve cardiac function and prognosis (CABG, PCI TAVI, mitraclip etc.)
  • INTERMACS profile 1 "crash and burn"
  • On-going mechanical circulatory support.
  • Heart failure due to restrictive cardiomyopathy pericardial disease, active myocarditis or uncorrected thyroid disease.
  • Mechanical aortic valve that will not be converted to a bioprosthesis or patch
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  • Moderate to severe aortic insufficiency without plans for correction
  • Technical obstacles, which pose an inordinately high surgical risk
  • Active, uncontrolled infection
  • 11. Stroke within 90 days or carotid artery stenosis > 80 % 12. Significant vascular disease. 13. Severe COPD or severe restrictive lung disease. 14. Intrinsic hepatic disease as defined by liver enzyme values (AST or ALT or total bilirubin) > 5 times the upper limit of normal, or INR > 2.0, which is not due to anti-coagulant therapy.
  • 15. Intolerance to anticoagulant or antiplatelet therapies or any other operative therapy the patient will require based upon the patient's health status.
  • 16. Platelet count < 50,000. 17. Measured GFR <20 ml/min/1.73m2 unresponsive to inotrope treatment or chronic dialysis.
  • 18. High risk for right ventricular failure according to echocardiography and/or invasive hemodynamic measurements as judged by the investigator (>2 parameter constitute an exclusion criteria) using a combination of the:
  • Severe TI b. TAPSE < 0.72 cm c. RVEDD/LVEDD > 0.72 d. CVP > 16 mm Hg e. MPAP - RAP < 10 mmHg SPAP-DPAP/CVPm >1 ok, <0.5 very bad, in between borderline f. CVP/PCWP > 0.63 g. RVSWI < 300 mm Hg x ml/m2 h. Bilirubin > 34 micromol/L 19. Body Mass Index (BMI) > 42 kg/m2. 20. Psychiatric disease, cognitive dysfunction, alcohol or drug abuse, or psychosocial issues that are likely to impair study compliance 21. Female of childbearing age with a positive pregnancy test or not willing to use adequate contraceptive precautions during the study.
  • 22. Condition, other than heart failure, that could limit survival to less than 2 years.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Sweden7 sites

  • Sahlgrenska Univesitetssjukhustet, Transplantationscentrum

    Gothenburg, 41234

  • Linköping Univ Hospital

    Linköping

  • Skåne University Hospital

    Lund

  • Örebro Univ Hospital

    Örebro

  • Karolinska Univ Hospital

    Stockholm

  • Univ Hospital of Umeå

    Umeå

  • Uppsala Univ Hospital

    Uppsala

Other trials in Sweden

About this study

Official title: Swedish Evaluation of Left Ventricular Assist Device

The study is a prospective, randomized, non-blinded, national, multi-center study. The study will consist of the assignment of eligible patients to treatment with either a HeartMate III (HM III) left ventricular assist device system or to pharmacological treatment (optimal medical management, OMM) according to current guidelines. Eighty (80) patients will be enrolled in this study and randomized in a 1:1 fashion between the HM III and OMM, based on a modified power calculation.

Read the detailed description

The primary objective is to compare survival between left Ventricular Assist Device (LVAD) destination therapy and optimal medical management in a Swedish end stage heart failure population ineligible for cardiac transplantation.

The secondary objective is to compare treatment groups with respect to organ function, functional capacity, quality of life and adverse events.

All patients enrolled in the study will be followed through 2 years. Patients who continue to be on going with the HM III or on OMM past 2 years will continue be followed for their outcomes and adverse events for up to 5 years. Patient recruitment was expected to occur over 24 months, but due to difficulties in recruiting patients will be longer (approximately 48 months)

The study will be conducted in Sweden at all 7 University Hospitals and implantations will be performed in 5 sites.

Being tested
HM III, OMM, optimal medical management
Keywords
HM III, survival, LVAD

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HM IIIDevice

    Also called left ventrical assist device, LVAD

  • OMM, optimal medical managementOther

    Patients randomized to OMM will be treated according to international guidelines. All patients should receive a beta blocker, an ACE-inhibitor or an Angiotension II receptor blocker, and a mineralocorticoid receptor antagonist if tolerated and at optimally titrated doses according to guidelines. Loop diuretics should also be used as needed to control fluid retention. Other drugs that may relieve symptoms and improve prognosis can be used (incl ivabradin, digoxin, hydralazine,isosorbiddinitrate, anticoagulant agents). Patients that have an indication for implantable cardioverter defibrillator (ICD) and/or cardiac resynchronization therapy (CRT) should receive such therapy. Surgical interventions that may be indicated for specific underlying or contributing causes of heart failure.

Study groups in NCT02592499
Study groupRoleWhat they receive
HM IIIExperimentalPatients randomized to mechanical circulatory support will be treated with the HeartMate III (HM III) left ventricular assist device system.
Receives: Device: HM III
OMM, Optimal Medical ManagementActive comparatorPatients randomized to OMM will be treated according to international guidelines. ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology. Eur Heart J. 2012 Jul;33(14):1787-84
Receives: Other: OMM, optimal medical management

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Survival at two years of follow-up

    survival

    Measured: 2 years,

Secondary outcomes (16)

  1. Number of participants free from disabling stroke during the 2-year follow-up period

    Survival free from disabling stroke (Modified Rankin Scale (MRS) >3)

    Measured: 2 years

  2. A composite endpoint of "survival free from disabling stroke", survival and non-planned hospitalizations

    Survival free from a composite endpoint of disabling stroke, survival and non-planned hospitalizations

    Measured: 2 years

  3. Survival at year of follow-up

    Survival at year

    Measured: 1 year

  4. Functional capacity (NYHA) during the 2-year follow-up period

    functional capacity determined by NYHA classification

    Measured: 2 years

  5. Functional capacity (6 min walk-test) during the 2-year follow-up period

    functional capacity determined by 6 min walk-test

    Measured: 2 years

  6. Functional capacity (peak VO2)

    functional capacity determined by peak VO2

    Measured: 2 years

  7. Health-related quality of Life during the 2-year follow-up period

    Health-related quality of Life asses with EQ-5D-5L, SF-36 and KCCQ

    Measured: 2 years

  8. Number of participants with heart-failure related events

    Measured: 2 years

  9. Cost-effectiveness during the 2-year follow-up period

    Cost effectiveness calculated with QUALY (Quality-adjusted Life-year) and LY (Life year)

    Measured: 2 years

  10. Renal function during the 2-year follow-up period

    Glomerular filtration rate evaluated by 51 chrome-EDTA or Iohexol clearance

    Measured: 2 years

  11. Hospital admissions during the 2-year follow-up period

    Number of hospital admissions

    Measured: 2 years

  12. Number of participants with serious adverse events (SAEs)

    Measured: 2 years

  13. Functional capacity (peak VO2)

    functional capacity determined by peak VO2

    Measured: 1 year

  14. Three-years survival

    survival

    Measured: 3 years

  15. Four-years survival

    survival

    Measured: 4 years

  16. Five-years survival

    survival

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2015 (estimated)
  2. Study startJun 2016
  3. Primary completionOct 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02592499
Sponsor's protocol ID
ver 6.0
Other IDs
635-14
Acronym
SweVAD
Status last verified
Jul 2026
First submitted
23 Oct 2015
Last updated
6 Jul 2026
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: We have not yet made an exact plan but see no reason for not sharing the data regarding IPD underlying the results of the study, as well as the protocol, SAP and ICF after publication, but will also depend on requirement by the journal upon publication.

Questions about this trial

What is this clinical trial studying?

A study testing HM III and OMM, optimal medical management in people with End-stage Heart Failure, run by Vastra Gotaland Region at 7 sites in Sweden.

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 15 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: under way, not looking for participants, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Sweden. 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?

This study is still under way. Results are not available in the source record yet.

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 at two years of follow-up (time frame: 2 years,). 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 NCT02592499.

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 6 Jul 2026.

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