{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,11]],"date-time":"2026-09-11T02:52:18Z","timestamp":1789095138671,"version":"build-2803163510"},"reference-count":16,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2020,2,28]],"date-time":"2020-02-28T00:00:00Z","timestamp":1582848000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cathet Cardio Intervent"],"published-print":{"date-parts":[[2020,6]]},"abstract":"Abstract<\/jats:title>Objective<\/jats:title>To evaluate safety and efficacy of the GORE\u00ae CARDIOFORM Septal Occluder for percutaneous transcatheter closure of ostium secundum<\/jats:italic> atrial septal defects.<\/jats:p><\/jats:sec>Background<\/jats:title>The GORE\u00ae CARDIOFORM septal occluder is a double\u2010disc, low profile, soft, conformable device, with distinct advantages over the GORE\u00ae HELEX\u00ae Septal Occluder.<\/jats:p><\/jats:sec>Methods<\/jats:title>Subjects were enrolled in this single arm prospective study from 21\u2009U.S. sites, and followed for 3\u2009years. Primary endpoint was 6 month composite clinical success, comprised of technical success (implantation and retention of device), closure success (normalization of right heart size), no 30\u2009day serious adverse events, and no device embolization or reintervention. Secondary endpoints included technical success, procedure success (technical success and\u2009\u2264\u20092\u2009mm residual shunt at procedure conclusion), closure success (clinically insignificant or no residual shunt), and safety (freedom from 30\u2009day serious adverse events and 6\u2010month device events).<\/jats:p><\/jats:sec>Results<\/jats:title>Between October 2012 and May 2015, 50 pivotal and 350 continued access subjects underwent attempted transcatheter GORE\u00ae CARDIOFORM Septal Occluder implantation. Median age was 6.9\u2009years, and mean static defect diameter 9.7\u2009\u00b1\u20093.1\u2009mm. Device placement was achieved in 93.5% (374\/400). Composite clinical success was 90.2% and clinical closure success was 98.8% at 6 months. Freedom from serious adverse events was 98.3% at 30\u2009days, with no device embolizations or reinterventions through 6 months.<\/jats:p><\/jats:sec>Conclusions<\/jats:title>The GORE\u00ae CARDIOFORM Septal Occluder has high composite clinical success and safety, performing well in defects \u226417\u2009mm by stop flow stretched diameter. Single, multifenestrated, and deficient retroaortic tissue defects were well represented and successfully treated.<\/jats:p><\/jats:sec>","DOI":"10.1002\/ccd.28814","type":"journal-article","created":{"date-parts":[[2020,2,28]],"date-time":"2020-02-28T15:12:27Z","timestamp":1582902747000},"page":"1296-1304","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":25,"title":["Use of the GORE\u00ae CARDIOFORM Septal Occluder for percutaneous closure of secundum atrial septal defects: Results of the multicenter U.S. IDE trial"],"prefix":"10.1002","volume":"95","author":[{"given":"Matthew J.","family":"Gillespie","sequence":"first","affiliation":[{"name":"The Children's Hospital of Philadelphia Philadelphia Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexander J.","family":"Javois","sequence":"additional","affiliation":[{"name":"Advocate Children's Hospital, Section of Pediatric Cardiology, University of Illinois Hospital Chicago Illinois"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Phillip","family":"Moore","sequence":"additional","affiliation":[{"name":"University of California San Francisco California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Forbes","sequence":"additional","affiliation":[{"name":"Children's Hospital of Michigan Detroit Michigan"}],"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":"Sanger Heart & Vascular Institute Levine Children's Hospital Charlotte North Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"for the GSO Investigator Group","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2020,2,28]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.105.592055"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.1976.03260490024013"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0735-1097(02)01862-4"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.115.019987"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2006.11.053"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.4244\/EIJV9I5A100"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/ccd.24851"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1002\/ccd.25494"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/ccd.25216"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1002\/ccd.26881"},{"key":"e_1_2_7_12_1","unstructured":"GORE\u00ae CARDIOFORM Septal Occluder IFU March 2018"},{"key":"e_1_2_7_13_1","unstructured":"GORE HELEX Septal Occluder IFU August 2006"},{"key":"e_1_2_7_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2014.01.169"},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.1002\/ccd.24987"},{"key":"e_1_2_7_16_1","doi-asserted-by":"publisher","DOI":"10.1002\/ccd.28103"},{"key":"e_1_2_7_17_1","first-page":"1","article-title":"Here today, gone tomorrow: outcomes of residual leak following secundum atrial septal defect closure with the Gore\u00ae CARDIOFORM Septal Occluder","author":"Gordon BM","year":"2019","journal-title":"Catheter Cardiovasc Interv"}],"container-title":["Catheterization and Cardiovascular 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