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
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 s...
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| Veröffentlicht in: | The American heart journal 2021-07, Vol.237, p.127-134 |
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| creator | Kiviniemi, Tuomas Bustamante-Munguira, Juan Olsson, Christian Jeppsson, Anders Halfwerk, Frank R. Hartikainen, Juha Suwalski, Piotr Zindovic, Igor Copa, Guillermo Reyes van Schaagen, F.R.N. Hanke, Thorsten Cebotari, Sergei Malmberg, Markus Fernandez-Gutierrez, Mireia Bjurbom, Markus Schersten, Henrik Speekenbrink, Ron Riekkinen, Teemu Ek, Danyal Vasankari, Tuija Lip, Gregory Y.H. Airaksinen, K.E. Juhani van Putte, Bart |
| description | 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. |
| doi_str_mv | 10.1016/j.ahj.2021.03.014 |
| format | Article |
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Juhani ; van Putte, Bart</creator><creatorcontrib>Kiviniemi, Tuomas ; Bustamante-Munguira, Juan ; Olsson, Christian ; Jeppsson, Anders ; Halfwerk, Frank R. ; Hartikainen, Juha ; Suwalski, Piotr ; Zindovic, Igor ; Copa, Guillermo Reyes ; van Schaagen, F.R.N. ; Hanke, Thorsten ; Cebotari, Sergei ; Malmberg, Markus ; Fernandez-Gutierrez, Mireia ; Bjurbom, Markus ; Schersten, Henrik ; Speekenbrink, Ron ; Riekkinen, Teemu ; Ek, Danyal ; Vasankari, Tuija ; Lip, Gregory Y.H. ; Airaksinen, K.E. Juhani ; van Putte, Bart ; for the LAA-CLOSURE Investigators ; LAA-CLOSURE Investigators</creatorcontrib><description>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.</description><identifier>ISSN: 0002-8703</identifier><identifier>ISSN: 1097-6744</identifier><identifier>EISSN: 1097-6744</identifier><identifier>DOI: 10.1016/j.ahj.2021.03.014</identifier><identifier>PMID: 33798494</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Aorta ; Aortic valve ; Brain research ; Cardiac and Cardiovascular Systems ; Cardiovascular diseases ; Clinical Medicine ; Clinical trials ; Computed tomography ; Congestive heart failure ; Consortia ; Design ; Echocardiography ; EKG ; Embolism ; Embolisms ; Fibrillation ; Heart failure ; Heart surgery ; Heart valves ; Hemoglobin ; Hemorrhage ; Kardiologi ; Klinisk medicin ; Medical and Health Sciences ; Medicin och hälsovetenskap ; Mortality ; Patients ; Prevention ; Risk management ; Safety ; Spinal cord ; Stroke ; Surgery ; Transient ischemic attack</subject><ispartof>The American heart journal, 2021-07, Vol.237, p.127-134</ispartof><rights>2021 The Author(s)</rights><rights>Copyright © 2021 The Author(s). Published by Elsevier Inc. All rights reserved.</rights><rights>2021. The Author(s)</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c619t-fd705d471cd0c53e9e1d475e4b920ba5508f4954cc8d3bc329548155b2f3c0173</citedby><cites>FETCH-LOGICAL-c619t-fd705d471cd0c53e9e1d475e4b920ba5508f4954cc8d3bc329548155b2f3c0173</cites><orcidid>0000-0002-0908-3741</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.proquest.com/docview/2532081752?pq-origsite=primo$$EHTML$$P50$$Gproquest$$H</linktohtml><link.rule.ids>230,314,552,780,784,885,3550,27924,27925,45995,64385,64387,64389,72469</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33798494$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://gup.ub.gu.se/publication/307160$$DView record from Swedish Publication Index$$Hfree_for_read</backlink><backlink>$$Uhttps://lup.lub.lu.se/record/b780d6b9-3fb5-49a9-b722-b57066485635$$DView record from Swedish Publication Index$$Hfree_for_read</backlink><backlink>$$Uhttp://kipublications.ki.se/Default.aspx?queryparsed=id:146803987$$DView record from Swedish Publication Index$$Hfree_for_read</backlink></links><search><creatorcontrib>Kiviniemi, Tuomas</creatorcontrib><creatorcontrib>Bustamante-Munguira, Juan</creatorcontrib><creatorcontrib>Olsson, Christian</creatorcontrib><creatorcontrib>Jeppsson, Anders</creatorcontrib><creatorcontrib>Halfwerk, Frank R.</creatorcontrib><creatorcontrib>Hartikainen, Juha</creatorcontrib><creatorcontrib>Suwalski, Piotr</creatorcontrib><creatorcontrib>Zindovic, Igor</creatorcontrib><creatorcontrib>Copa, Guillermo Reyes</creatorcontrib><creatorcontrib>van Schaagen, F.R.N.</creatorcontrib><creatorcontrib>Hanke, Thorsten</creatorcontrib><creatorcontrib>Cebotari, Sergei</creatorcontrib><creatorcontrib>Malmberg, Markus</creatorcontrib><creatorcontrib>Fernandez-Gutierrez, Mireia</creatorcontrib><creatorcontrib>Bjurbom, Markus</creatorcontrib><creatorcontrib>Schersten, Henrik</creatorcontrib><creatorcontrib>Speekenbrink, Ron</creatorcontrib><creatorcontrib>Riekkinen, Teemu</creatorcontrib><creatorcontrib>Ek, Danyal</creatorcontrib><creatorcontrib>Vasankari, Tuija</creatorcontrib><creatorcontrib>Lip, Gregory Y.H.</creatorcontrib><creatorcontrib>Airaksinen, K.E. Juhani</creatorcontrib><creatorcontrib>van Putte, Bart</creatorcontrib><creatorcontrib>for the LAA-CLOSURE Investigators</creatorcontrib><creatorcontrib>LAA-CLOSURE Investigators</creatorcontrib><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</title><title>The American heart journal</title><addtitle>Am Heart J</addtitle><description>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.</description><subject>Aorta</subject><subject>Aortic valve</subject><subject>Brain research</subject><subject>Cardiac and Cardiovascular Systems</subject><subject>Cardiovascular diseases</subject><subject>Clinical Medicine</subject><subject>Clinical trials</subject><subject>Computed tomography</subject><subject>Congestive heart failure</subject><subject>Consortia</subject><subject>Design</subject><subject>Echocardiography</subject><subject>EKG</subject><subject>Embolism</subject><subject>Embolisms</subject><subject>Fibrillation</subject><subject>Heart failure</subject><subject>Heart surgery</subject><subject>Heart valves</subject><subject>Hemoglobin</subject><subject>Hemorrhage</subject><subject>Kardiologi</subject><subject>Klinisk medicin</subject><subject>Medical and Health Sciences</subject><subject>Medicin och hälsovetenskap</subject><subject>Mortality</subject><subject>Patients</subject><subject>Prevention</subject><subject>Risk management</subject><subject>Safety</subject><subject>Spinal cord</subject><subject>Stroke</subject><subject>Surgery</subject><subject>Transient ischemic attack</subject><issn>0002-8703</issn><issn>1097-6744</issn><issn>1097-6744</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>8G5</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><sourceid>D8T</sourceid><recordid>eNp9kstu1DAYhSMEglJ4ADbIEhs2GezYzkWsRlW5SCNVArq2fPkz9TQTBzsZNKx4B16ONU_CH2ZaJKRWiuVLvnNyFJ8se8HoglFWvtks9NVmUdCCLShfUCYeZCeMNlVeVkI8zE4opUVeV5Q_yZ6mtMFtWdTl4-wJ51VTi0acZL-WJOreha3_Do4MMaQB7Oh3QLZTN3oL_QiRjNHrjrQhkjTGcA0Iwg5f-dATs59lw9W-0yi0JE1x7S3itgu4BhJaMl4B6aAdiT446WGA3uk1EN-TQY8evRKZegdxHXy_JsaHOQvqZksd4jztdIe5Zn-I-98_fuKzWi7zs9XF58tP58eQKBuDDd2z7FGruwTPj_Npdvnu_MvZh3x18f7j2XKV25I1Y966ikonKmYdtZJDAwx3EoRpCmq0lLRuRSOFtbXjxvIC1zWT0hQtt5RV_DTLD77pGwyTUUP0Wx33KmivjkfXuAIlSs6oQL65k8fs7p_oRshEWVPe1PO3Vndqu2nAYXDMGlPV1JWmUbw1UolGN3hUFMrIipalqGXJ5b3R12iHR-u_bpxWrKTIvz7wmPPrBGlUW58sdJ3uIUxJFfizZFVjXkRf_YduwhR7vAikeEFrVskCKXagLN51itDeRmBUzQ1XG4UNV3PDFeUKG46al0fnyWzB3SpuKo3A2wMAeOs7D1Eli_2y4HzEaisX_D32fwBXuBQI</recordid><startdate>20210701</startdate><enddate>20210701</enddate><creator>Kiviniemi, Tuomas</creator><creator>Bustamante-Munguira, Juan</creator><creator>Olsson, Christian</creator><creator>Jeppsson, Anders</creator><creator>Halfwerk, Frank R.</creator><creator>Hartikainen, Juha</creator><creator>Suwalski, Piotr</creator><creator>Zindovic, Igor</creator><creator>Copa, Guillermo Reyes</creator><creator>van Schaagen, F.R.N.</creator><creator>Hanke, Thorsten</creator><creator>Cebotari, Sergei</creator><creator>Malmberg, Markus</creator><creator>Fernandez-Gutierrez, Mireia</creator><creator>Bjurbom, Markus</creator><creator>Schersten, Henrik</creator><creator>Speekenbrink, Ron</creator><creator>Riekkinen, Teemu</creator><creator>Ek, Danyal</creator><creator>Vasankari, Tuija</creator><creator>Lip, Gregory Y.H.</creator><creator>Airaksinen, K.E. 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Juhani</au><au>van Putte, Bart</au><aucorp>for the LAA-CLOSURE Investigators</aucorp><aucorp>LAA-CLOSURE Investigators</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>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</atitle><jtitle>The American heart journal</jtitle><addtitle>Am Heart J</addtitle><date>2021-07-01</date><risdate>2021</risdate><volume>237</volume><spage>127</spage><epage>134</epage><pages>127-134</pages><issn>0002-8703</issn><issn>1097-6744</issn><eissn>1097-6744</eissn><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.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>33798494</pmid><doi>10.1016/j.ahj.2021.03.014</doi><tpages>8</tpages><orcidid>https://orcid.org/0000-0002-0908-3741</orcidid><oa>free_for_read</oa></addata></record> |
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| identifier | ISSN: 0002-8703 |
| ispartof | The American heart journal, 2021-07, Vol.237, p.127-134 |
| issn | 0002-8703 1097-6744 1097-6744 |
| language | eng |
| recordid | cdi_swepub_primary_oai_swepub_ki_se_463104 |
| source | SWEPUB Freely available online; Access via ScienceDirect (Elsevier); ProQuest Central UK/Ireland |
| subjects | Aorta Aortic valve Brain research Cardiac and Cardiovascular Systems Cardiovascular diseases Clinical Medicine Clinical trials Computed tomography Congestive heart failure Consortia Design Echocardiography EKG Embolism Embolisms Fibrillation Heart failure Heart surgery Heart valves Hemoglobin Hemorrhage Kardiologi Klinisk medicin Medical and Health Sciences Medicin och hälsovetenskap Mortality Patients Prevention Risk management Safety Spinal cord Stroke Surgery Transient ischemic attack |
| 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 | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-12-29T09%3A50%3A59IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_swepu&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=A%20randomized%20prospective%20multicenter%20trial%20for%20stroke%20prevention%20by%20prophylactic%20surgical%20closure%20of%20the%20left%20atrial%20appendage%20in%20patients%20undergoing%20bioprosthetic%20aortic%20valve%20surgery%E2%80%93%E2%80%93LAA-CLOSURE%20trial%20protocol&rft.jtitle=The%20American%20heart%20journal&rft.au=Kiviniemi,%20Tuomas&rft.aucorp=for%20the%20LAA-CLOSURE%20Investigators&rft.date=2021-07-01&rft.volume=237&rft.spage=127&rft.epage=134&rft.pages=127-134&rft.issn=0002-8703&rft.eissn=1097-6744&rft_id=info:doi/10.1016/j.ahj.2021.03.014&rft_dat=%3Cproquest_swepu%3E2508578146%3C/proquest_swepu%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2532081752&rft_id=info:pmid/33798494&rft_els_id=S0002870321000879&rfr_iscdi=true |