Kiviniemi, Tuomas, Bustamante-Munguira, Juan, Olsson, Christian, Jeppsson, Anders, Halfwerk, Frank R, Hartikainen, Juha, Suwalski, Piotr, Zindovic, Igor, Copa, Guillermo Reyes, van Schaagen, FRN et al (show 13 more authors)
(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, 237.
pp. 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 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.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | LAA-CLOSURE Investigators, Atrial Appendage, Humans, Atrial Fibrillation, Aortic Valve Stenosis, Echocardiography, Transesophageal, Cardiac Surgical Procedures, Heart Valve Prosthesis Implantation, Follow-Up Studies, Prospective Studies, Bioprosthesis, Aged, Female, Male, Stroke |
| Divisions: | Faculty of Health and Life Sciences Faculty of Health and Life Sciences > Institute of Life Courses and Medical Sciences |
| Depositing User: | Symplectic Admin |
| Date Deposited: | 25 Sep 2023 13:23 |
| Last Modified: | 25 Sep 2023 13:23 |
| DOI: | 10.1016/j.ahj.2021.03.014 |
| Open Access URL: | https://doi.org/10.1016/j.ahj.2021.03.014 |
| Related URLs: | |
| URI: | https://livrepository.liverpool.ac.uk/id/eprint/3173023 |
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