Swedish Evaluation of Left Ventricular Assist Device
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- End-stage Heart Failure
- Sponsor
- Vastra Gotaland Region
- Enrollment
- 80
- Locations
- 7
- Primary Endpoint
- Survival at two years of follow-up
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief 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 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.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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:
- •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.
Exclusion Criteria
- •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
- •Moderate to severe aortic insufficiency without plans for correction
- •Technical obstacles, which pose an inordinately high surgical risk
- •Active, uncontrolled infection
- •Stroke within 90 days or carotid artery stenosis \> 80 %
Outcomes
Primary Outcomes
Survival at two years of follow-up
Time Frame: 2 years,
survival
Secondary Outcomes
- Survival at year of follow-up(1 year)
- Hospital admissions during the 2-year follow-up period(2 years)
- Number of participants free from disabling stroke during the 2-year follow-up period(2 years)
- Five-years survival(5 years)
- A composite endpoint of "survival free from disabling stroke", survival and non-planned hospitalizations(2 years)
- Health-related quality of Life during the 2-year follow-up period(2 years)
- Number of participants with heart-failure related events(2 years)
- Three-years survival(3 years)
- Four-years survival(4 years)
- Functional capacity (NYHA) during the 2-year follow-up period(2 years)
- Functional capacity (6 min walk-test) during the 2-year follow-up period(2 years)
- Functional capacity (peak VO2)(1 year)
- Cost-effectiveness during the 2-year follow-up period(2 years)
- Renal function during the 2-year follow-up period(2 years)
- Number of participants with serious adverse events (SAEs)(2 years)