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Search: WFRF:(Jeppsson A) > Zindovic Igor > Halfwerk F. R. > A randomized prospe...

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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

Kiviniemi, T. (author)
Turku University Hospital,Harvard Medical School
Bustamante-Munguira, J. (author)
University of Valladolid
Olsson, C. (author)
Karolinska Institute,Karolinska Institutet,Karolinska University Hospital
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Jeppsson, Anders, 1960 (author)
Gothenburg 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
Halfwerk, F. R. (author)
Medisch Spectrum Twente
Hartikainen, J. (author)
Kuopio University Hospital
Suwalski, P. (author)
Ministry of Interior and Administration Republic of Poland, Central Clinical Hospital
Zindovic, Igor (author)
Lund 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
Copa, G. R. (author)
Hospital Universitario de la Princesa
van Schaagen, F. R. N. (author)
Erasmus University Medical Center
Hanke, T. (author)
Asklepios Kliniken Hamburg GmbH
Cebotari, S. (author)
Hannover Medical School
Malmberg, M. (author)
Karolinska Institutet,Turku University Hospital
Fernandez-Gutierrez, M. (author)
University of Valladolid
Bjurbom, M. (author)
Karolinska University Hospital
Schersten, Henrik (author)
Gothenburg University,Göteborgs universitet,Institutionen för medicin, avdelningen för molekylär och klinisk medicin,Institute of Medicine, Department of Molecular and Clinical Medicine,Sahlgrenska University Hospital
Speekenbrink, R. (author)
Medisch Spectrum Twente
Riekkinen, T. (author)
Kuopio University Hospital
Ek, Danyal (author)
Lund University,Lunds universitet,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Department of Clinical Sciences, Lund,Faculty of Medicine,Skåne University Hospital
Vasankari, T. (author)
Turku University Hospital
Lip, G. Y. H. (author)
University of Liverpool
Airaksinen, K. E. J. (author)
Turku University Hospital
van Putte, B. (author)
St. Antonius Hospital
for the, L. A. A. Closure Investigators (author)
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 (creator_code:org_t)
Elsevier BV, 2021
2021
English.
In: American Heart Journal. - : Elsevier BV. - 0002-8703 .- 1097-6744. ; 237, s. 127-134
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  • Journal article (peer-reviewed)
Abstract Subject headings
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  • 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)

Subject headings

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Kardiologi (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Cardiac and Cardiovascular Systems (hsv//eng)

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