{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T21:21:17Z","timestamp":1790803277865,"version":"4.1.0"},"reference-count":10,"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":[[2023,10,3]]},"abstract":"<jats:sec sec-type=\"background\" xml:lang=\"en\">\n            <jats:title>Background<\/jats:title>\n            <jats:p xml:lang=\"en\">Self\u2010administration of investigational intranasal L\u2010type calcium channel blocker etripamil during paroxysmal supraventricular tachycardia (PSVT) appeared safe and well\u2010tolerated in the phase 3 NODE\u2010301 (Multi\u2010Centre, Randomized, Double\u2010Blind, Placebo\u2010Controlled, Efficacy, and Safety Study of Etripamil Nasal Spray for the Termination of Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia) trial of adults with sustained atrioventricular nodal\u2010dependent PSVT. The NODE\u2010302 open\u2010label extension further characterized etripamil safety and efficacy.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec xml:lang=\"en\">\n            <jats:title>Methods and Results<\/jats:title>\n            <jats:p xml:lang=\"en\">\n              Eligible patients were monitored via self\u2010applied cardiac monitoring system for 5\u2009hours after etripamil self\u2010administration. The primary end point was time\u2010to\u2010conversion of positively adjudicated PSVT to sinus rhythm after etripamil treatment. Probability of conversion to sinus rhythm was reported via Kaplan\u2010Meier plot. Adverse events were based on self\u2010reported symptoms and clinical evaluations. Among 169 patients enrolled, 105 self\u2010administered etripamil \u22651 time for perceived PSVT (median [range], 232 [8\u2013584] days' follow\u2010up). Probability of conversion within 30\u2009minutes of etripamil was 60.2% (median time to conversion, 15.5\u2009minutes) among 188 PSVT episodes (92 patients) positively adjudicated as atrioventricular nodal dependent by independent ECG analysis. Among 40 patients who self\u2010treated 2 episodes, 75% had a significantly consistent response by 30\u2009minutes; 9 did not convert on either episode, and 21 converted on both episodes (\u03c7\n              <jats:sup>2<\/jats:sup>\n              =8.09;\n              <jats:italic>P<\/jats:italic>\n              =0.0045). Forty\u2010five of 105 patients (42.9%) had \u22651 treatment\u2010emergent adverse event, generally transient and mild\u2010to\u2010moderate, including nasal congestion (14.3%), nasal discomfort (14.3%), or rhinorrhea (12.4%). No serious cardiac safety events were observed within 24\u2009hours of etripamil.\n            <\/jats:p>\n          <\/jats:sec>\n          <jats:sec xml:lang=\"en\">\n            <jats:title>Conclusions<\/jats:title>\n            <jats:p xml:lang=\"en\">In this extension study, investigational etripamil nasal spray was well tolerated for self\u2010treating recurrent episodes of PSVT without medical supervision.<\/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: NCT03635996.\n            <\/jats:p>\n          <\/jats:sec>","DOI":"10.1161\/jaha.122.028227","type":"journal-article","created":{"date-parts":[[2023,9,27]],"date-time":"2023-09-27T09:30:13Z","timestamp":1695807013000},"update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":13,"title":["Etripamil Nasal Spray for Conversion of Repeated Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia During Long\u2010Term Follow\u2010Up: Results From the NODE\u2010302 Study"],"prefix":"10.1161","volume":"12","author":[{"given":"James E.","family":"Ip","sequence":"first","affiliation":[{"name":"Weill Cornell Medicine, New York\u2010Presbyterian Hospital New York NY USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Benoit","family":"Coutu","sequence":"additional","affiliation":[{"name":"Centre Hospitalier de l\u2019Universit\u00e9 de Montr\u00e9al Montreal Quebec Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthew T.","family":"Bennett","sequence":"additional","affiliation":[{"name":"Centre for Cardiovascular Innovation Division of Cardiology University of British Columbia Vancouver British Columbia Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2307-2376","authenticated-orcid":false,"given":"A. Shekhar","family":"Pandey","sequence":"additional","affiliation":[{"name":"Cambridge Cardiac Care Centre Cambridge Ontario Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bruce S.","family":"Stambler","sequence":"additional","affiliation":[{"name":"Piedmont Heart Institute Atlanta GA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7055-1786","authenticated-orcid":false,"given":"Philip","family":"Sager","sequence":"additional","affiliation":[{"name":"Cardiovascular Research Institute and Department of Medicine Stanford University Palo Alto CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Chen","sequence":"additional","affiliation":[{"name":"TCM Groups, Inc Berkeley Heights NJ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Silvia","family":"Shardonofsky","sequence":"additional","affiliation":[{"name":"Milestone Pharmaceuticals Montreal Quebec Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4436-5218","authenticated-orcid":false,"given":"Francis","family":"Plat","sequence":"additional","affiliation":[{"name":"Milestone Pharmaceuticals Montreal Quebec Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2536-2871","authenticated-orcid":false,"given":"A. John","family":"Camm","sequence":"additional","affiliation":[{"name":"St. George\u2019s University of London London United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","reference":[{"key":"e_1_3_2_2_2","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehz467"},{"key":"e_1_3_2_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.hrthm.2015.09.018"},{"key":"e_1_3_2_4_2","doi-asserted-by":"publisher","DOI":"10.1136\/pgmj.50.585.447"},{"key":"e_1_3_2_5_2","doi-asserted-by":"publisher","DOI":"10.1161\/01.cir.0000059743.36226.e8"},{"key":"e_1_3_2_6_2","doi-asserted-by":"publisher","DOI":"10.1016\/s0735-1097(00)01128-1"},{"key":"e_1_3_2_7_2","doi-asserted-by":"publisher","DOI":"10.1161\/01.cir.71.1.104"},{"key":"e_1_3_2_8_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2018.04.082"},{"key":"e_1_3_2_9_2","doi-asserted-by":"publisher","DOI":"10.1161\/circep.122.010915"},{"key":"e_1_3_2_10_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.amjcard.2019.10.015"},{"key":"e_1_3_2_11_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.hrthm.2015.09.019"}],"container-title":["Journal of the American Heart Association"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.ahajournals.org\/doi\/full\/10.1161\/JAHA.122.028227","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,5,13]],"date-time":"2024-05-13T12:54:43Z","timestamp":1715604883000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.ahajournals.org\/doi\/10.1161\/JAHA.122.028227"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,10,3]]},"references-count":10,"journal-issue":{"issue":"19","published-print":{"date-parts":[[2023,10,3]]}},"alternative-id":["10.1161\/JAHA.122.028227"],"URL":"https:\/\/doi.org\/10.1161\/jaha.122.028227","relation":{},"ISSN":["2047-9980"],"issn-type":[{"value":"2047-9980","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,10,3]]},"assertion":[{"value":"2022-12-13","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-07-07","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-09-27","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e028227"}}