{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,25]],"date-time":"2026-08-25T23:08:21Z","timestamp":1787699301631,"version":"build-2784847793"},"reference-count":31,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2020,6,15]],"date-time":"2020-06-15T00:00:00Z","timestamp":1592179200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2020,6,15]],"date-time":"2020-06-15T00:00:00Z","timestamp":1592179200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"Meril Life Sciences Pvt. 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The purpose of Dafodil-1 first-in-human trial was to evaluate clinical safety and performance (including hemodynamic parameters) of the Dafodil pericardial bioprosthesis in patients who underwent aortic or mitral valve replacement.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Methods<\/jats:title>\n<jats:p>This prospective, multicenter clinical trial enrolled 60 patients (Aortic: 30 patients; Mitral: 30 patients) from seven sites across India. Safety endpoints were early (\u226430\u2009days) and late (&gt;\u200930\u2009days) mortality and valve-related morbidity. The performance endpoints were hemodynamic performance, improvement in NYHA functional class, and change in the quality of life using SF-12v1 health survey.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Results<\/jats:title>\n<jats:p>From July 2017 to July 2018, 60 patients underwent implantation of the Dafodil pericardial bioprosthesis. Post-operatively, NYHA functional class significantly improved in all the patients (Aortic: 90% NYHA class-I and 10% NYHA class-II; Mitral: 96.55% NYHA class-I and 3.45% NYHA class-II; <jats:italic>P<\/jats:italic>\u2009&lt;\u20090.001). There was no death in aortic valve replacement patients till 12-month. In mitral valve replacement patients, early mortalities occurred in three patients, and late mortality occurred in one patient; none of these were valve-related. Freedom from all-cause mortality reported was 93.33% at 12-month. Mean aortic pressure gradient decreased from 52.71\u2009\u00b1\u200924.47\u2009mmHg [with 0.89\u2009\u00b1\u20090.70\u2009cm<jats:sup>2<\/jats:sup> effective orifice area (EOA)] pre-operatively to 14.49\u2009\u00b1\u20096.58\u2009mmHg (EOA: 1.85\u2009\u00b1\u20090.27\u2009cm<jats:sup>2<\/jats:sup>) at 12-month. Overall, the mitral mean pressure gradient and EOA were 4.41\u2009\u00b1\u20091.69\u2009mmHg and 2.67\u2009\u00b1\u20090.48\u2009cm<jats:sup>2<\/jats:sup>, respectively, at 12-month. Significant improvement (<jats:italic>P<\/jats:italic>\u2009&lt;\u20090.05) in the patients\u2019 quality of life was reported at all follow-ups.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Conclusions<\/jats:title>\n<jats:p>The clinical safety and performance of the Dafodil pericardial bioprosthesis were favourable at 12-month. Moreover, a study with a larger patient population and longer follow-up is warranted to further assess the device.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Trial registration<\/jats:title>\n<jats:p>Dafodil-1 trial has been prospectively registered on 10\/07\/2017 under Clinical Trial Registry-India (<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/ctri.nic.in\/Clinicaltrials\/showallp.php?mid1=18377&amp;EncHid=&amp;userName=CTRI\/2017\/07\/009008\">http:\/\/www.ctri.nic.in<\/jats:ext-link>). (Registration number: <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/ctri.nic.in\/Clinicaltrials\/showallp.php?mid1=18377&amp;EncHid=&amp;userName=CTRI\/2017\/07\/009008\">CTRI\/2017\/07\/009008<\/jats:ext-link>).<\/jats:p>\n<\/jats:sec>","DOI":"10.1186\/s13019-020-01154-7","type":"journal-article","created":{"date-parts":[[2020,6,15]],"date-time":"2020-06-15T09:04:09Z","timestamp":1592211849000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Clinical outcomes and hemodynamic performance of Dafodil\u2122 aortic and mitral pericardial bioprosthesis: 1-year results from Dafodil-1 first-in-human trial"],"prefix":"10.1186","volume":"15","author":[{"given":"C. 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Y. Patil Vidyapeeth, Pune, Narayana Health Medical Ethics Committee, Institutional Ethics Committee Sanjay Gandhi Postgraduate Institute of Medical Sciences, Institutional ethics Committee, Fortis Escort Heart Institute, and Institutional ethics Committee of B. J. Government Medical College & Sassoon General hospitals, Pune. Written informed consent was obtained from each of the patients before starting any trial-related activity.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Obtained from the participants.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"All the authors declare that they have no competing interests.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"140"}}