Swedish Evaluation of Left Ventricular Assist Device as Permanent Treatment in End-stage Heart Fa… (NCT02592499) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Swedish Evaluation of Left Ventricular Assist Device as Permanent Treatment in End-stage Heart Failure
Sweden74 participantsStarted 2016-06
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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