{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,7]],"date-time":"2026-10-07T06:52:48Z","timestamp":1791355968337,"version":"4.3.1"},"reference-count":28,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"19","content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["JAHA"],"published-print":{"date-parts":[[2026,10,6]]},"abstract":"<jats:sec xml:lang=\"en\">\n                    <jats:title>Background<\/jats:title>\n                    <jats:p xml:lang=\"en\">Traditional occluders for atrial septal defect have 2 drawbacks: incomplete endothelialization and difficulty in achieving atrial septum puncture post implantation. The novel occluder ReAces was designed to address these 2 clinical pain points. In this study, we aimed to compare the efficacy and safety of ReAces with a traditional Amplatzer\u2010like atrial septal defect occluder.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec xml:lang=\"en\">\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p xml:lang=\"en\">This was a multicenter, randomized, parallel\u2010controlled, noninferiority clinical trial. Patients with atrial septal defects were enrolled and randomly implanted with a ReAces or a traditional Amplatzer\u2010like occluder. The primary outcome was complete closure rate at 12 months post implantation. The Migraine Disability Assessment scores before and after the procedure were recorded.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec xml:lang=\"en\">\n                    <jats:title>Results<\/jats:title>\n                    <jats:p xml:lang=\"en\">\n                      Sixty\u2010two patients were implanted with ReAces and 64 patients with a traditional occluder. At the 12\u2010month follow\u2010up, complete closure was achieved in 61 patients in the trial group (98.4%) and 63 patients in the control group (98.4%), which demonstrated noninferiority (95% CI, \u22124.4% to 4.3%). No severe adverse events occurred during 12 months of follow\u2010up except a case of device dislodgement in the trial group. The thickness of the central region of ReAces at the 12\u2010month follow\u2010up was significantly lower than that of the traditional device (6.8\u00b13.7\u2009mm versus 12.2\u00b15.2,\n                      <jats:italic toggle=\"no\">P<\/jats:italic>\n                      &lt;0.0001). The trial group showed a significantly lower Migraine Disability Assessment score (0.4\u00b12.4 versus 1.4\u00b14.1,\n                      <jats:italic toggle=\"no\">P<\/jats:italic>\n                      =0.042) and a lower proportion of patients with a nonzero Migraine Disability Assessment score (5.6% versus 18.2%,\n                      <jats:italic toggle=\"no\">P<\/jats:italic>\n                      =0.042) at the 1\u2010month follow\u2010up.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec xml:lang=\"en\">\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p xml:lang=\"en\">The efficacy of ReAces was noninferior to that of a traditional Amplatzer\u2010like occluder for transcatheter atrial septal defect closure. ReAces had a thinner central region during the follow\u2010up and a lower Migraine Disability Assessment score at the 1\u2010month follow\u2010up.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec xml:lang=\"en\">\n                    <jats:title>Registration<\/jats:title>\n                    <jats:p xml:lang=\"en\">\n                      URL:\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.clinicaltrials.gov\">https:\/\/www.clinicaltrials.gov<\/jats:ext-link>\n                      ; Unique identifier: NCT05371366.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1161\/jaha.125.045052","type":"journal-article","created":{"date-parts":[[2026,9,18]],"date-time":"2026-09-18T13:23:22Z","timestamp":1789737802000},"update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["Comparison of a Novel Occluder Versus Traditional Occluder in Atrial Septal Defect: A Randomized Trial"],"prefix":"10.1161","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0009-0009-5564-5061","authenticated-orcid":false,"given":"Yanxing","family":"Fang","sequence":"first","affiliation":[{"name":"Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases","place":["Shanghai, China"]},{"name":"National Clinical Research Center for Interventional Medicine","place":["Shanghai, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mingfei","family":"Li","sequence":"additional","affiliation":[{"name":"Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases","place":["Shanghai, China"]},{"name":"National Clinical Research Center for Interventional Medicine","place":["Shanghai, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3111-2665","authenticated-orcid":false,"given":"Zhihui","family":"Zhang","sequence":"additional","affiliation":[{"name":"Center for Circadian Metabolism and Cardiovascular Disease, Southwest Hospital, Army Medical University","place":["Chongqing, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caojin","family":"Zhang","sequence":"additional","affiliation":[{"name":"Guangdong Cardiovascular Institute, Guangdong Provincial People\u2019s Hospital, Guangdong Academy of Medical Sciences, Southern Medical University","place":["Guangzhou, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhenfei","family":"Fang","sequence":"additional","affiliation":[{"name":"The Second Xiangya Hospital, Central South University","place":["Hunan, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-9412-273X","authenticated-orcid":false,"given":"Donghui","family":"Zhang","sequence":"additional","affiliation":[{"name":"Second Affiliated Hospital of Harbin Medical University","place":["Harbin, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0008-5846-3733","authenticated-orcid":false,"given":"Haitao","family":"Liu","sequence":"additional","affiliation":[{"name":"Xijing Hospital, Fourth Military Medical University","place":["Xi\u2019an, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0530-261X","authenticated-orcid":false,"given":"Wenzhi","family":"Pan","sequence":"additional","affiliation":[{"name":"Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases","place":["Shanghai, China"]},{"name":"National Clinical Research Center for Interventional Medicine","place":["Shanghai, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-9814-3630","authenticated-orcid":false,"given":"Daxin","family":"Zhou","sequence":"additional","affiliation":[{"name":"Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases","place":["Shanghai, China"]},{"name":"National Clinical Research Center for Interventional Medicine","place":["Shanghai, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9360-7332","authenticated-orcid":false,"given":"Junbo","family":"Ge","sequence":"additional","affiliation":[{"name":"Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases","place":["Shanghai, China"]},{"name":"National Clinical Research Center for Interventional Medicine","place":["Shanghai, 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