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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, Tuomas ; Bustamante-Munguira, Juan ; Olsson, Christian ; Jeppsson, Anders ; Halfwerk, Frank R. ; Hartikainen, Juha ; Suwalski, Piotr ; Zindovic, Igor LU ; Copa, Guillermo Reyes and van Schaagen, F. R.N. , et al. (2021) In American Heart Journal 237. p.127-134
Abstract

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... (More)

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.

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type
Contribution to journal
publication status
published
subject
in
American Heart Journal
volume
237
pages
8 pages
publisher
Mosby-Elsevier
external identifiers
  • scopus:85107319152
  • pmid:33798494
ISSN
1097-6744
DOI
10.1016/j.ahj.2021.03.014
language
English
LU publication?
yes
id
b780d6b9-3fb5-49a9-b722-b57066485635
date added to LUP
2021-06-24 14:33:56
date last changed
2024-04-06 05:33:06
@article{b780d6b9-3fb5-49a9-b722-b57066485635,
  abstract     = {{<p>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.</p>}},
  author       = {{Kiviniemi, Tuomas and Bustamante-Munguira, Juan and Olsson, Christian and Jeppsson, Anders and Halfwerk, Frank R. and Hartikainen, Juha and Suwalski, Piotr and Zindovic, Igor and Copa, Guillermo Reyes and van Schaagen, F. R.N. and Hanke, Thorsten and Cebotari, Sergei and Malmberg, Markus and Fernandez-Gutierrez, Mireia and Bjurbom, Markus and Schersten, Henrik and Speekenbrink, Ron and Riekkinen, Teemu and Ek, Danyal and Vasankari, Tuija and Lip, Gregory Y.H. and Airaksinen, K. E.Juhani and van Putte, Bart}},
  issn         = {{1097-6744}},
  language     = {{eng}},
  month        = {{07}},
  pages        = {{127--134}},
  publisher    = {{Mosby-Elsevier}},
  series       = {{American Heart Journal}},
  title        = {{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}},
  url          = {{http://dx.doi.org/10.1016/j.ahj.2021.03.014}},
  doi          = {{10.1016/j.ahj.2021.03.014}},
  volume       = {{237}},
  year         = {{2021}},
}