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Swedish Evaluation of Left Ventricular Assist Device (SweVAD)
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.
Details
| Lead sponsor | Vastra Gotaland Region |
|---|---|
| Phase | NA |
| Status | UNKNOWN |
| Enrolment | 80 |
| Start date | 2016-06 |
| Completion | 2025-12 |
Conditions
- End-stage Heart Failure
Interventions
- HM III
- OMM, optimal medical management
Primary outcomes
- Survival at two years of follow-up — 2 years,
survival
Countries
Sweden