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Randomized trial of...
Randomized trial of a left ventricular assist device as destination therapy versus guideline-directed medical therapy in patients with advanced heart failure. Rationale and design of the SWEdish evaluation of left Ventricular Assist Device (SweVAD) trial
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- Karason, Kristjan, 1962 (author)
- Gothenburg University,Göteborgs universitet,Institutionen för medicin,Institute of Medicine,Sahlgrens Univ Hosp, Sweden
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- Hübbert, Laila, Docent, 1964- (author)
- Karolinska Institutet,Linköpings universitet,Avdelningen för diagnostik och specialistmedicin,Medicinska fakulteten,Region Östergötland, Kardiologiska kliniken i Norrköping
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- Dalen, M. (author)
- Karolinska Institutet
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- Bjorklund, E. (author)
- Uppsala Univ Hosp, Sweden
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- Grinnemo, K. (author)
- Uppsala Univ Hosp, Sweden
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- Braun, O. (author)
- Skane Univ Hosp, Sweden
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- Nilsson, J. (author)
- Skane Univ Hosp, Sweden
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- van der Wal, Henriette (author)
- Region Östergötland, Kardiologiska kliniken US
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- Holm, Jonas, 1971- (author)
- Linköpings universitet,Avdelningen för diagnostik och specialistmedicin,Medicinska fakulteten,Region Östergötland, Thorax-kärlkliniken i Östergötland
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Hubbert, L. (author)
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- Lindmark, K. (author)
- Umea Univ Hosp, Sweden
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- Szabo, B. (author)
- Orebro Univ Hosp, Sweden
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- Holmberg, E. (author)
- Sahlgrens Univ Hosp, Sweden
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- Dellgren, Göran, 1961 (author)
- Sahlgrens Univ Hosp, Sweden
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Swe, V. A. D. Investigators (author)
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(creator_code:org_t)
- 2020-02-26
- 2020
- English.
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In: European Journal of Heart Failure. - : Wiley. - 1388-9842 .- 1879-0844. ; 22:2, s. 739-50
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Abstract
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- Aims Patients with advanced heart failure (AdHF) who are ineligible for heart transplantation (HTx) can become candidates for treatment with a left ventricular assist device (LVAD) in some countries, but not others. This reflects the lack of a systematic analysis of the usefulness of LVAD systems in this context, and of their benefits, limitations and cost-effectiveness. The SWEdish evaluation of left Ventricular Assist Device (SweVAD) study is a Phase IV, prospective, 1:1 randomized, non-blinded, multicentre trial that will examine the impact of assignment to mechanical circulatory support with guideline-directed LVAD destination therapy (GD-LVAD-DT) using the HeartMate 3 (HM3) continuous flow pump vs. guideline-directed medical therapy (GDMT) on survival in a population of AdHF patients ineligible for HTx. Methods A total of 80 patients will be recruited to SweVAD at the seven university hospitals in Sweden. The study population will comprise patients with AdHF (New York Heart Association class IIIB-IV, INTERMACS profile 2-6) who display signs of poor prognosis despite GDMT and who are not considered eligible for HTx. Participants will be followed for 2 years or until death occurs. Other endpoints will be determined by blinded adjudication. Patients who remain on study-assigned interventions beyond 2 years will be asked to continue follow-up for outcomes and adverse events for up to 5 years. Conclusion The SweVAD study will compare survival, medium-term benefits, costs and potential hazards between GD-LVAD-DT and GDMT and will provide a valuable reference point to guide destination therapy strategies for patients with AdHF ineligible for HTx.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kardiologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cardiac and Cardiovascular Systems (hsv//eng)
Keyword
- Advanced heart failure
- Destination therapy
- Mechanical circulatory
- support
- Left ventricular assist device
- HeartMate 3
- Guideline-directed
- medical therapy
- Randomized controlled trial
- management
- outcomes
- Cardiovascular System & Cardiology
- Advanced heart failure; Destination therapy; Mechanical circulatory support; Left ventricular assist device; HeartMate 3; Guideline-directed medical therapy; Randomized controlled trial
Publication and Content Type
- ref (subject category)
- art (subject category)
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- By the author/editor
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Karason, Kristja ...
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Hübbert, Laila, ...
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Dalen, M.
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Bjorklund, E.
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Grinnemo, K.
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Braun, O.
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show more...
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Nilsson, J.
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van der Wal, Hen ...
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Holm, Jonas, 197 ...
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Hubbert, L.
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Lindmark, K.
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Szabo, B.
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Holmberg, E.
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Dellgren, Göran, ...
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Swe, V. A. D. In ...
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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Cardiac and Card ...
- Articles in the publication
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European Journal ...
- By the university
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University of Gothenburg
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Linköping University
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Karolinska Institutet