{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,17]],"date-time":"2026-06-17T01:29:29Z","timestamp":1781659769900,"version":"3.54.5"},"reference-count":33,"publisher":"Elsevier BV","license":[{"start":{"date-parts":[[2020,8,1]],"date-time":"2020-08-01T00:00:00Z","timestamp":1596240000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2020,8,1]],"date-time":"2020-08-01T00:00:00Z","timestamp":1596240000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"}],"funder":[{"DOI":"10.13039\/100004312","name":"Eli Lilly and Company","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004312","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100015340","name":"Bayer Fund","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100015340","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100004325","name":"AstraZeneca","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004325","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100005035","name":"Biotronik","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100005035","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100004336","name":"Novartis","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004336","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100005646","name":"Actelion Pharmaceuticals","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005646","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100002429","name":"Amgen","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100002429","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100008497","name":"Boston Scientific Corporation","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100008497","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100001003","name":"Boehringer Ingelheim","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100001003","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100001316","name":"Abbott Laboratories","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100001316","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100007150","name":"United Therapeutics Corporation","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100007150","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["clinicalkey.com","clinicalkey.com.au","clinicalkey.es","clinicalkey.fr","clinicalkey.jp","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["American Heart Journal"],"published-print":{"date-parts":[[2020,8]]},"DOI":"10.1016\/j.ahj.2019.10.015","type":"journal-article","created":{"date-parts":[[2019,11,11]],"date-time":"2019-11-11T18:58:38Z","timestamp":1573498718000},"page":"222-231","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":39,"special_numbering":"C","title":["Transcatheter InterAtrial Shunt Device for the treatment of heart failure: Rationale and design of the pivotal randomized trial to REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure II (REDUCE LAP-HF II)"],"prefix":"10.1016","volume":"226","author":[{"given":"Natalia","family":"Berry","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura","family":"Mauri","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ted","family":"Feldman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jan","family":"Komtebedde","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dirk J.","family":"van Veldhuisen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Scott D.","family":"Solomon","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joseph M.","family":"Massaro","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sanjiv J.","family":"Shah","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"issue":"1","key":"10.1016\/j.ahj.2019.10.015_bb0005","doi-asserted-by":"crossref","first-page":"4","DOI":"10.1002\/ehf2.12005","article-title":"Heart failure: preventing disease and death worldwide","volume":"1","author":"Ponikowski","year":"2014","journal-title":"ESC Heart Fail"},{"issue":"10","key":"10.1016\/j.ahj.2019.10.015_bb0010","doi-asserted-by":"crossref","first-page":"e146","DOI":"10.1161\/CIR.0000000000000485","article-title":"Heart disease and stroke statistics\u20142017 update: a report from the American Heart Association","volume":"135","author":"Benjamin","year":"2017","journal-title":"Circulation"},{"issue":"4","key":"10.1016\/j.ahj.2019.10.015_bb0015","doi-asserted-by":"crossref","first-page":"401","DOI":"10.1007\/s11897-013-0155-7","article-title":"The emerging epidemic of heart failure with preserved ejection fraction","volume":"10","author":"Oktay","year":"2013","journal-title":"Curr Heart Fail Rep"},{"issue":"6","key":"10.1016\/j.ahj.2019.10.015_bb0020","doi-asserted-by":"crossref","first-page":"1037","DOI":"10.1007\/s00424-014-1480-8","article-title":"Heart failure with preserved ejection fraction","volume":"466","author":"Gladden","year":"2014","journal-title":"Pflugers Arch"},{"issue":"19","key":"10.1016\/j.ahj.2019.10.015_bb0025","doi-asserted-by":"crossref","first-page":"1868","DOI":"10.1056\/NEJMcp1511175","article-title":"Heart failure with preserved ejection fraction","volume":"375","author":"Redfield","year":"2016","journal-title":"N Engl J Med"},{"issue":"6","key":"10.1016\/j.ahj.2019.10.015_bb0030","doi-asserted-by":"crossref","first-page":"526","DOI":"10.1016\/j.jacc.2009.06.067","article-title":"Treatment of heart failure with normal ejection fraction: an inconvenient truth","volume":"55","author":"Paulus","year":"2010","journal-title":"J Am Coll Cardiol"},{"issue":"1","key":"10.1016\/j.ahj.2019.10.015_bb0035","doi-asserted-by":"crossref","first-page":"73","DOI":"10.1161\/CIRCULATIONAHA.116.021884","article-title":"Phenotype-specific treatment of heart failure with preserved ejection fraction: a multiorgan roadmap","volume":"134","author":"Shah","year":"2016","journal-title":"Circulation"},{"issue":"9","key":"10.1016\/j.ahj.2019.10.015_bb0040","doi-asserted-by":"crossref","first-page":"972","DOI":"10.1016\/j.jacc.2006.10.061","article-title":"Ventricular structure and function in hypertensive participants with heart failure and a normal ejection fraction: the Cardiovascular Health Study","volume":"49","author":"Maurer","year":"2007","journal-title":"J Am Coll Cardiol"},{"issue":"9","key":"10.1016\/j.ahj.2019.10.015_bb0045","doi-asserted-by":"crossref","first-page":"702","DOI":"10.1016\/j.cardfail.2012.06.530","article-title":"Hemodynamic determinants of the abnormal cardiopulmonary exercise response in heart failure with preserved left ventricular ejection fraction","volume":"18","author":"Maeder","year":"2012","journal-title":"J Card Fail"},{"issue":"1","key":"10.1016\/j.ahj.2019.10.015_bb0050","doi-asserted-by":"crossref","first-page":"20","DOI":"10.1253\/circj.CJ-13-1103","article-title":"Mechanisms of exercise intolerance in heart failure with preserved ejection fraction","volume":"78","author":"Borlaug","year":"2014","journal-title":"Circ J"},{"issue":"5","key":"10.1016\/j.ahj.2019.10.015_bb0055","doi-asserted-by":"crossref","first-page":"588","DOI":"10.1161\/CIRCHEARTFAILURE.109.930701","article-title":"Exercise hemodynamics enhance diagnosis of early heart failure with preserved ejection fraction","volume":"3","author":"Borlaug","year":"2010","journal-title":"Circ Heart Fail"},{"issue":"19","key":"10.1016\/j.ahj.2019.10.015_bb0060","doi-asserted-by":"crossref","first-page":"1953","DOI":"10.1056\/NEJMoa032566","article-title":"Diastolic heart failure\u2014abnormalities in active relaxation and passive stiffness of the left ventricle","volume":"350","author":"Zile","year":"2004","journal-title":"N Engl J Med"},{"issue":"6","key":"10.1016\/j.ahj.2019.10.015_bb0065","doi-asserted-by":"crossref","first-page":"429","DOI":"10.1016\/j.jchf.2014.12.017","article-title":"The hospitalization burden and post-hospitalization mortality risk in heart failure with preserved ejection fraction: results from the I-PRESERVE trial (Irbesartan in Heart Failure and Preserved Ejection Fraction)","volume":"3","author":"Carson","year":"2015","journal-title":"JACC Heart Fail"},{"issue":"44","key":"10.1016\/j.ahj.2019.10.015_bb0070","doi-asserted-by":"crossref","first-page":"3103","DOI":"10.1093\/eurheartj\/ehu315","article-title":"Pulmonary capillary wedge pressure during exercise and long-term mortality in patients with suspected heart failure with preserved ejection fraction","volume":"35","author":"Dorfs","year":"2014","journal-title":"Eur Heart J"},{"issue":"1","key":"10.1016\/j.ahj.2019.10.015_bb0075","doi-asserted-by":"crossref","DOI":"10.1161\/CIRCHEARTFAILURE.116.003594","article-title":"Intracardiac pressures measured using an implantable hemodynamic monitor: relationship to mortality in patients with chronic heart failure","volume":"10","author":"Zile","year":"2017","journal-title":"Circ Heart Fail"},{"key":"10.1016\/j.ahj.2019.10.015_bb0080","first-page":"237","article-title":"De la Stenose mitrale avec communication interauriculaire","volume":"9","author":"Lutembacher","year":"1916","journal-title":"Arch Mal Coeur"},{"issue":"6","key":"10.1016\/j.ahj.2019.10.015_bb0085","doi-asserted-by":"crossref","first-page":"681","DOI":"10.1016\/0002-9149(58)90264-9","article-title":"Pathologic physiology of Lutembacher syndrome","volume":"2","author":"Sambhi","year":"1958","journal-title":"Am J Cardiol"},{"issue":"5005","key":"10.1016\/j.ahj.2019.10.015_bb0090","doi-asserted-by":"crossref","first-page":"1351","DOI":"10.1136\/bmj.2.5005.1351","article-title":"Atrial septal defect with mitral stenosis (Lutembacher's syndrome) in a woman of 81","volume":"2","author":"Rosenthal","year":"1956","journal-title":"Br Med J"},{"issue":"3","key":"10.1016\/j.ahj.2019.10.015_bb0095","doi-asserted-by":"crossref","first-page":"212","DOI":"10.1016\/j.cardfail.2014.01.005","article-title":"Effects of an interatrial shunt on rest and exercise hemodynamics: results of a computer simulation in heart failure","volume":"20","author":"Kaye","year":"2014","journal-title":"J Card Fail"},{"issue":"7","key":"10.1016\/j.ahj.2019.10.015_bb0100","doi-asserted-by":"crossref","first-page":"796","DOI":"10.1002\/ejhf.111","article-title":"Transcatheter treatment of heart failure with preserved or mildly reduced ejection fraction using a novel interatrial implant to lower left atrial pressure","volume":"16","author":"Sondergaard","year":"2014","journal-title":"Eur J Heart Fail"},{"key":"10.1016\/j.ahj.2019.10.015_bb0105","doi-asserted-by":"crossref","first-page":"227","DOI":"10.1016\/j.ijcard.2015.03.198","article-title":"Clinical outcome of transcatheter treatment of heart failure with preserved or mildly reduced ejection fraction using a novel implant","volume":"187","author":"Malek","year":"2015","journal-title":"Int J Cardiol"},{"issue":"10025","key":"10.1016\/j.ahj.2019.10.015_bb0110","doi-asserted-by":"crossref","first-page":"1298","DOI":"10.1016\/S0140-6736(16)00704-2","article-title":"A transcatheter intracardiac shunt device for heart failure with preserved ejection fraction (REDUCE LAP-HF): a multicentre, open-label, single-arm, phase 1 trial","volume":"387","author":"Hasenfuss","year":"2016","journal-title":"Lancet"},{"issue":"7","key":"10.1016\/j.ahj.2019.10.015_bb0115","doi-asserted-by":"crossref","first-page":"594","DOI":"10.1016\/j.cardfail.2015.05.008","article-title":"Rationale and design of the reduce elevated left atrial pressure in patients with heart failure (Reduce LAP-HF) trial","volume":"21","author":"Hasenfuss","year":"2015","journal-title":"J Card Fail"},{"issue":"12","key":"10.1016\/j.ahj.2019.10.015_bb0120","doi-asserted-by":"crossref","DOI":"10.1161\/CIRCHEARTFAILURE.116.003662","article-title":"One-year outcomes after transcatheter insertion of an interatrial shunt device for the management of heart failure with preserved ejection fraction","volume":"9","author":"Kaye","year":"2016","journal-title":"Circ Heart Fail"},{"issue":"7","key":"10.1016\/j.ahj.2019.10.015_bb0125","doi-asserted-by":"crossref","DOI":"10.1161\/CIRCHEARTFAILURE.116.003025","article-title":"Transcatheter interatrial shunt device for the treatment of heart failure: rationale and design of the randomized trial to REDUCE Elevated Left Atrial Pressure in Heart Failure (REDUCE LAP-HF I)","volume":"9","author":"Feldman","year":"2016","journal-title":"Circ Heart Fail"},{"issue":"4","key":"10.1016\/j.ahj.2019.10.015_bb0130","doi-asserted-by":"crossref","first-page":"364","DOI":"10.1161\/CIRCULATIONAHA.117.032094","article-title":"Transcatheter interatrial shunt device for the treatment of heart failure with preserved ejection fraction (REDUCE LAP-HF I [Reduce Elevated Left Atrial Pressure in Patients With Heart Failure]): a phase 2, randomized, sham-controlled trial","volume":"137","author":"Feldman","year":"2018","journal-title":"Circulation"},{"issue":"10","key":"10.1016\/j.ahj.2019.10.015_bb0135","doi-asserted-by":"crossref","first-page":"968","DOI":"10.1001\/jamacardio.2018.2936","volume":"3","author":"Shah","year":"2018","journal-title":"JAMA Cardiol"},{"issue":"11","key":"10.1016\/j.ahj.2019.10.015_bb0140","doi-asserted-by":"crossref","first-page":"1341","DOI":"10.1002\/(SICI)1097-0258(19990615)18:11<1341::AID-SIM129>3.0.CO;2-7","article-title":"Combining mortality and longitudinal measures in clinical trials","volume":"18","author":"Finkelstein","year":"1999","journal-title":"Stat Med"},{"issue":"2","key":"10.1016\/j.ahj.2019.10.015_bb0145","doi-asserted-by":"crossref","first-page":"176","DOI":"10.1093\/eurheartj\/ehr352","article-title":"The win ratio: a new approach to the analysis of composite endpoints in clinical trials based on clinical priorities","volume":"33","author":"Pocock","year":"2012","journal-title":"Eur Heart J"},{"issue":"28","key":"10.1016\/j.ahj.2019.10.015_bb0150","doi-asserted-by":"crossref","first-page":"3267","DOI":"10.1002\/sim.4102","article-title":"Adaptive increase in sample size when interim results are promising: a practical guide with examples","volume":"30","author":"Mehta","year":"2011","journal-title":"Stat Med"},{"issue":"27","key":"10.1016\/j.ahj.2019.10.015_bb0155","doi-asserted-by":"crossref","first-page":"4681","DOI":"10.1002\/sim.6274","article-title":"Relaxing the independent censoring assumption in the Cox proportional hazards model using multiple imputation","volume":"33","author":"Jackson","year":"2014","journal-title":"Stat Med"},{"issue":"9","key":"10.1016\/j.ahj.2019.10.015_bb0160","doi-asserted-by":"crossref","first-page":"1086","DOI":"10.1161\/CIRCULATIONAHA.108.800490","article-title":"Physician-directed patient self-management of left atrial pressure in advanced chronic heart failure","volume":"121","author":"Ritzema","year":"2010","journal-title":"Circulation"},{"issue":"5","key":"10.1016\/j.ahj.2019.10.015_bb0165","doi-asserted-by":"crossref","first-page":"1245","DOI":"10.1016\/S0735-1097(00)00531-3","article-title":"Development and evaluation of the Kansas City Cardiomyopathy Questionnaire: a new health status measure for heart failure","volume":"35","author":"Green","year":"2000","journal-title":"J Am Coll Cardiol"}],"container-title":["American Heart Journal"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0002870319302972?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0002870319302972?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2025,11,2]],"date-time":"2025-11-02T09:57:44Z","timestamp":1762077464000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0002870319302972"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,8]]},"references-count":33,"alternative-id":["S0002870319302972"],"URL":"https:\/\/doi.org\/10.1016\/j.ahj.2019.10.015","relation":{},"ISSN":["0002-8703"],"issn-type":[{"value":"0002-8703","type":"print"}],"subject":[],"published":{"date-parts":[[2020,8]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Transcatheter InterAtrial Shunt Device for the treatment of heart failure: Rationale and design of the pivotal randomized trial to REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure II (REDUCE LAP-HF II)","name":"articletitle","label":"Article Title"},{"value":"American Heart Journal","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.ahj.2019.10.015","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2019 Elsevier Inc. All rights reserved.","name":"copyright","label":"Copyright"}]}}