{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,1]],"date-time":"2026-07-01T02:02:39Z","timestamp":1782871359435,"version":"3.54.5"},"reference-count":17,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2020,1,14]],"date-time":"2020-01-14T00:00:00Z","timestamp":1578960000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"name":"WL GORE & Associates"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cathet Cardio Intervent"],"published-print":{"date-parts":[[2020,6]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objective<\/jats:title><jats:p>Assess clinical performance of a new device for transcatheter closure of atrial septal defect (ASD).<\/jats:p><\/jats:sec><jats:sec><jats:title>Background<\/jats:title><jats:p>Previously\u2010approved ASD Closure devices have known limitations. Device erosion has been associated with the AMPLATZER\u00ae septal occluder in patients with retro\u2010aortic rim deficiency (&lt;5\u2009mm), while defects \u226518\u2009mm are too large for the GORE\u00ae CARDIOFORM septal occluder. The GORE\u00ae CARDIOFORM ASD occluder (GCA), a hybrid of the approved devices, was designed to expand the eligible ASD population.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>One\u2010hundred and twenty\u2010five ASD patients were enrolled in a prospective, multicenter registry. Descriptive clinical endpoints included: technical implant success, closure success, serious adverse events (SAE), clinically significant new arrhythmia, and wire frame fracture. Procedural outcomes and adverse events were adjudicated by an Echocardiography Core Lab and Independent Data Review Board, respectively.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Median subject age was 12.3\u2009years (range 2.9\u201384.7), with 72% of patients \u226418\u2009years old. Median ASD stop\u2010flow diameter was 17.0\u2009mm (8.0\u201330.0), with 43% \u226518\u2009mm. Deficient retro\u2010aortic rim occurred in 57% of subjects, and 30% had both diameter\u2009\u2265\u200918\u2009mm and deficient rim. Technical Implant Success was achieved in 120\/125 (96%), though three devices were removed within 24\u2009hr. At the scheduled 6\u2010month evaluation, 112\/117 returned for evaluation. All 112 had closure success. SAE occurred in 6\/125 (4.8%) and 6\/125 (4.8%) had clinically significant new arrhythmia. Wire frame fractures occurred in 37\/104 (36%), without any associated clinical sequelae, residual shunt, or device instability.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The GCA performed effectively and safely in this initial cohort, and led to FDA approval based on this data.<\/jats:p><\/jats:sec>","DOI":"10.1002\/ccd.28728","type":"journal-article","created":{"date-parts":[[2020,1,14]],"date-time":"2020-01-14T13:00:30Z","timestamp":1579006830000},"page":"1285-1295","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":41,"title":["ASSURED clinical study: New GORE\u00ae CARDIOFORM ASD occluder for transcatheter closure of atrial septal defect"],"prefix":"10.1002","volume":"95","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9280-6236","authenticated-orcid":false,"given":"Robert J.","family":"Sommer","sequence":"first","affiliation":[{"name":"Department of Medicine, Division of Interventional Cardiology Columbia University Medical Center  New York New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Barry A.","family":"Love","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Division of Pediatric Cardiology Mount Sinai Medical Center  New York New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0726-1337","authenticated-orcid":false,"given":"Joseph A.","family":"Paolillo","sequence":"additional","affiliation":[{"name":"Atrium Health Sanger Heart &amp; Vascular Institute  Charlotte North Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8913-0543","authenticated-orcid":false,"given":"Robert G.","family":"Gray","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Division of Pediatric Cardiology University of Utah  Salt Lake City Utah"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8508-9523","authenticated-orcid":false,"given":"Bryan H.","family":"Goldstein","sequence":"additional","affiliation":[{"name":"Cincinnati Children's Hospital Medical Center  Cincinnati Ohio"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1500-9334","authenticated-orcid":false,"given":"Gareth J.","family":"Morgan","sequence":"additional","affiliation":[{"name":"The Heart Institute Children's Hospital of Colorado  Aurora Colorado"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthew J.","family":"Gillespie","sequence":"additional","affiliation":[{"name":"Children's Hospital of Philadelphia University of Pennsylvania  Philadelphia Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"for the ASSURED Investigators","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2020,1,14]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0735-1097(02)01886-7"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.105.592055"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.108.190690"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0022-5223(19)40065-2"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCINTERVENTIONS.116.004212"},{"key":"e_1_2_8_7_1","unstructured":"AbbottMedical(2019).AMPLATZER\u00ae Septal Occluder Instructions For Use:https:\/\/www.structuralheartsolutions.com\/us\/structural\u2010heart\u2010products\u2010solutions\/asd\u2010amplatzer\u2010septal\u2010occlude\/overview\/?gclid=Cj0KCQjwt5zsBRD8ARIsAJfI4BhjiYD\u201053Q9i4OUjjEqY8h3O\u2010dmsL93pRodsb6O7J6NdxbC4EBuFDsaAm_xEALw_wcB."},{"key":"e_1_2_8_8_1","unstructured":"W.L. 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