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  • Kiviniemi, T.Turku University Hospital,Harvard Medical School (author)

A randomized prospective multicenter trial for stroke prevention by prophylactic surgical closure of the left atrial appendage in patients undergoing bioprosthetic aortic valve surgery––LAA-CLOSURE trial protocol

  • Article/chapterEnglish2021

Publisher, publication year, extent ...

  • Elsevier BV,2021

Numbers

  • LIBRIS-ID:oai:gup.ub.gu.se/307160
  • https://gup.ub.gu.se/publication/307160URI
  • https://doi.org/10.1016/j.ahj.2021.03.014DOI
  • http://kipublications.ki.se/Default.aspx?queryparsed=id:146803987URI
  • https://lup.lub.lu.se/record/b780d6b9-3fb5-49a9-b722-b57066485635URI

Supplementary language notes

  • Language:English

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  • Subject category:ref swepub-contenttype
  • Subject category:art swepub-publicationtype

Notes

  • Patients undergoing surgical aortic valve replacement (SAVR) are at high risk for atrial fibrillation (AF) and stroke after surgery. There is an unmet clinical need to improve stroke prevention in this patient population. The LAA-CLOSURE trial aims to assess the efficacy and safety of prophylactic surgical closure of the left atrial appendage for stroke and cardiovascular death prevention in patients undergoing bioprosthetic SAVR. This randomized, open-label, prospective multicenter trial will enroll 1,040 patients at 13 European sites. The primary endpoint is a composite of cardiovascular mortality, stroke and systemic embolism at 5 years. Secondary endpoints include cardiovascular mortality, stroke, systemic embolism, bleed fulfilling academic research consortium (BARC) criteria, hospitalization for decompensated heart failure and health economic evaluation. Sample size is based on 30% risk reduction in time to event analysis of primary endpoint. Prespecified reports include 30-day safety analysis focusing on AF occurrence and short-term outcomes and interim analyses at 1 and 3 years for primary and secondary outcomes. Additionally, substudies will be performed on the completeness of the closure using transesophageal echocardiography/cardiac computed tomography and long-term ECG recording at one year after the operation. © 2021 The Author(s)

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Added entries (persons, corporate bodies, meetings, titles ...)

  • Bustamante-Munguira, J.University of Valladolid (author)
  • Olsson, C.Karolinska Institute,Karolinska Institutet,Karolinska University Hospital (author)
  • Jeppsson, Anders,1960Gothenburg University,Göteborgs universitet,Institutionen för medicin, avdelningen för molekylär och klinisk medicin,Institute of Medicine, Department of Molecular and Clinical Medicine,Sahlgrenska Academy,Sahlgrenska University Hospital(Swepub:gu)xjepan (author)
  • Halfwerk, F. R.Medisch Spectrum Twente (author)
  • Hartikainen, J.Kuopio University Hospital (author)
  • Suwalski, P.Ministry of Interior and Administration Republic of Poland, Central Clinical Hospital (author)
  • Zindovic, IgorLund University,Lunds universitet,Thoraxkirurgi,Sektion II,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Thoracic Surgery,Section II,Department of Clinical Sciences, Lund,Faculty of Medicine,Skåne University Hospital(Swepub:lu)med-izn (author)
  • Copa, G. R.Hospital Universitario de la Princesa (author)
  • van Schaagen, F. R. N.Erasmus University Medical Center (author)
  • Hanke, T.Asklepios Kliniken Hamburg GmbH (author)
  • Cebotari, S.Hannover Medical School (author)
  • Malmberg, M.Karolinska Institutet,Turku University Hospital (author)
  • Fernandez-Gutierrez, M.University of Valladolid (author)
  • Bjurbom, M.Karolinska University Hospital (author)
  • Schersten, HenrikGothenburg University,Göteborgs universitet,Institutionen för medicin, avdelningen för molekylär och klinisk medicin,Institute of Medicine, Department of Molecular and Clinical Medicine,Sahlgrenska University Hospital (author)
  • Speekenbrink, R.Medisch Spectrum Twente (author)
  • Riekkinen, T.Kuopio University Hospital (author)
  • Ek, DanyalLund University,Lunds universitet,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Department of Clinical Sciences, Lund,Faculty of Medicine,Skåne University Hospital(Swepub:lu)med-dne (author)
  • Vasankari, T.Turku University Hospital (author)
  • Lip, G. Y. H.University of Liverpool (author)
  • Airaksinen, K. E. J.Turku University Hospital (author)
  • van Putte, B.St. Antonius Hospital (author)
  • for the, L. A. A. Closure Investigators (author)
  • Turku University HospitalHarvard Medical School (creator_code:org_t)

Related titles

  • In:American Heart Journal: Elsevier BV237, s. 127-1340002-87031097-6744

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