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Swedish Evaluation of Left Ventricular Assist Device as Permanent Treatment in End-stage Heart Failure
Sponsor: Vastra Gotaland Region
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.
Official title: Swedish Evaluation of Left Ventricular Assist Device
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
74
Start Date
2016-06
Completion Date
2026-12
Last Updated
2026-07-06
Healthy Volunteers
No
Conditions
Interventions
HM III
OMM, optimal medical management
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.
Locations (7)
Sahlgrenska Univesitetssjukhustet, Transplantationscentrum
Gothenburg, Sweden
Linköping Univ Hospital
Linköping, Sweden
Skåne University Hospital
Lund, Sweden
Örebro Univ Hospital
Örebro, Sweden
Karolinska Univ Hospital
Stockholm, Sweden
Univ Hospital of Umeå
Umeå, Sweden
Uppsala Univ Hospital
Uppsala, Sweden