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
| Autor: | Guillermo Reyes Copa, Igor Zindovic, Henrik Scherstén, Juha Hartikainen, Gregory Y.H. Lip, Piotr Suwalski, Markus Bjurbom, Laa-Closure Investigators, Tuomas Kiviniemi, Teemu Riekkinen, Danyal Ek, Mireia Fernandez-Gutierrez, Ron G.H. Speekenbrink, Juan Bustamante-Munguira, Thorsten Hanke, K.E. Juhani Airaksinen, Markus Malmberg, F. R.N. van Schaagen, F.R. Halfwerk, Tuija Vasankari, Bart P. van Putte, Christian Olsson, Sergei Cebotari, Anders Jeppsson |
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| Přispěvatelé: | Cardiothoracic Surgery, Biomechanical Engineering, TechMed Centre |
| Rok vydání: | 2021 |
| Předmět: |
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medicine.medical_specialty 030204 cardiovascular system & hematology law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial Aortic valve replacement law Multicenter trial Atrial Fibrillation medicine Clinical endpoint Humans Atrial Appendage Prospective Studies 030212 general & internal medicine Cardiac Surgical Procedures Stroke Aged Randomised controlled trial Bioprosthesis Heart Valve Prosthesis Implantation business.industry Atrial fibrillation Aortic Valve Stenosis Cardiac surgery medicine.disease Surgery Heart failure Female cerebrovascular accident Cardiology and Cardiovascular Medicine business Echocardiography Transesophageal study protocol Follow-Up Studies |
| Zdroj: | American Heart Journal, 237, 127-134. Mosby Inc. Kiviniemi, T, Bustamante-Munguira, J, Olsson, C, Jeppsson, A, Halfwerk, F R, Hartikainen, J, Suwalski, P, Zindovic, I, Copa, G R, van Schaagen, F R N, Hanke, T, Cebotari, S, Malmberg, M, Fernandez-Gutierrez, M, Bjurbom, M, Schersten, H, Speekenbrink, R, Riekkinen, T, Ek, D, Vasankari, T, Lip, G Y H, Airaksinen, K E J, van Putte, B & LAA-CLOSURE Investigators 2021, ' 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 ', American Heart Journal, vol. 237, pp. 127-134 . https://doi.org/10.1016/j.ahj.2021.03.014 American heart journal, 237, 127-134. Mosby Inc. |
| ISSN: | 0002-8703 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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