{"id":3308,"date":"2023-05-03T11:45:08","date_gmt":"2023-05-03T09:45:08","guid":{"rendered":"https:\/\/rythmologie.fr\/index\/?p=3308"},"modified":"2023-05-03T15:05:33","modified_gmt":"2023-05-03T13:05:33","slug":"newsletter-mai-2023-fih-clinical-trial-etude-du-catheter-single-shot-affera-presentation-du-design-de-letude-v-reddy-usa","status":"publish","type":"post","link":"https:\/\/rythmologie.fr\/index\/newsletter-mai-2023-fih-clinical-trial-etude-du-catheter-single-shot-affera-presentation-du-design-de-letude-v-reddy-usa\/","title":{"rendered":" Newsletter Mai 2023 – FIH clinical trial : ..."},"content":{"rendered":"

[vc_row][vc_column css=”.vc_custom_1663235123898{margin-top: 0px !important;border-top-width: 0px !important;background-color: rgba(255,255,255,0.1) !important;*background-color: rgb(255,255,255) !important;}”]

<\/div>

Newsletter Groupe Rythmologie \u2013 Stimulation cardiaque de la SFC<\/h2><\/div>
Mai 2023<\/div><\/div>[vc_empty_space height=”24px”][vc_separator color=”custom” accent_color=”#e42925″][\/vc_column][\/vc_row][vc_row][vc_column]
<\/div>

FIH clinical trial : Etude du catheter single shot (Affera) : presentation du design de l\u2019etude (V Reddy, USA)<\/h3><\/div>
<\/p>\n
\n
\n
\n
\n
\n
\n
\n
\n
\n

Auteur :\u00a0<\/em>Estelle GANDJBAKHCH – Paris<\/em><\/p>\n

 <\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n

<\/div><\/div>[vc_empty_space height=”24px”][vc_column_text]<\/p>\n

Le design de l’\u00e9tude FIH a \u00e9t\u00e9 pr\u00e9sent\u00e9 \u00e0 l’EHRA. Il s’agit d’une \u00e9tude prospective, \u00e0 un seul bras, multicentrique ayant pour objectif d’\u00e9valuer la s\u00e9curit\u00e9 et l’efficacit\u00e9 du syst\u00e8me \u00ab Comfortable PFA \u00bb dans l’ablation de FA paroxystique. Il est pr\u00e9vu d’inclure 160 patients qui seront suivis pendant 1 an apr\u00e8s l’ablation. Les crit\u00e8res d’inclusion sont les patients ayant une FA paroxystique avec au moins 2 \u00e9pisodes document\u00e9s et \u00e9chec d’au moins un traitement antiarythmique. Les patients avec FA persistante, un indice de masse corporelle (IMC) sup\u00e9rieur \u00e0 40, un diam\u00e8tre de l’oreillette gauche sup\u00e9rieur \u00e0 50 cm et une fraction d’\u00e9jection ventriculaire gauche inf\u00e9rieure \u00e0 40% sont exclus. Le crit\u00e8re de jugement principal est la s\u00e9curit\u00e9, l’incidence de survenue d’effets secondaires pendant la proc\u00e9dure et sur l’efficacit\u00e9 ; le succ\u00e8s d’isolation des veines pulmonaires en aigu. Les crit\u00e8res de jugement secondaires sont le taux de patients ayant une complication li\u00e9e au dispositif, la durabilit\u00e9 des l\u00e9sions valid\u00e9es par une nouvelle cartographie et la survie sans r\u00e9cidive d’arythmie atriale \u00e0 12 mois. L’\u00e9tude a commenc\u00e9 les inclusions en juillet 2021 et 66 patients sont d\u00e9j\u00e0 inclus. Il est pr\u00e9vu de pr\u00e9senter les r\u00e9sultats \u00e0 l’EHRA en 2024.<\/p>\n

[\/vc_column_text][vc_empty_space height=”24px”][vc_empty_space height=”24px”][\/vc_column][\/vc_row][vc_row][vc_column][vc_empty_space][vc_empty_space][vc_separator][vc_empty_space][\/vc_column][\/vc_row]<\/p>\n","protected":false},"excerpt":{"rendered":"

[vc_row][vc_column css=”.vc_custom_1663235123898{margin-top: 0px !important;border-top-width: 0px !important;background-color: rgba(255,255,255,0.1) !important;*background-color: rgb(255,255,255) !important;}”][vc_empty_space height=”24px”][vc_separator color=”custom” accent_color=”#e42925″][\/vc_column][\/vc_row][vc_row][vc_column][vc_empty_space height=”24px”][vc_column_text] Le design de l’\u00e9tude FIH a \u00e9t\u00e9 pr\u00e9sent\u00e9 \u00e0 l’EHRA. Il s’agit d’une \u00e9tude prospective, \u00e0 un seul bras, multicentrique ayant pour objectif d’\u00e9valuer la s\u00e9curit\u00e9 et l’efficacit\u00e9 du syst\u00e8me \u00ab Comfortable PFA \u00bb dans l’ablation de FA paroxystique. Il est…<\/p>\n","protected":false},"author":2,"featured_media":3345,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":"","_links_to":"","_links_to_target":""},"categories":[31,22],"tags":[],"class_list":["post-3308","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-newsletter","category-articles","category-31","category-22","description-off"],"_links":{"self":[{"href":"https:\/\/rythmologie.fr\/index\/wp-json\/wp\/v2\/posts\/3308","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/rythmologie.fr\/index\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/rythmologie.fr\/index\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/rythmologie.fr\/index\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/rythmologie.fr\/index\/wp-json\/wp\/v2\/comments?post=3308"}],"version-history":[{"count":3,"href":"https:\/\/rythmologie.fr\/index\/wp-json\/wp\/v2\/posts\/3308\/revisions"}],"predecessor-version":[{"id":3347,"href":"https:\/\/rythmologie.fr\/index\/wp-json\/wp\/v2\/posts\/3308\/revisions\/3347"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/rythmologie.fr\/index\/wp-json\/wp\/v2\/media\/3345"}],"wp:attachment":[{"href":"https:\/\/rythmologie.fr\/index\/wp-json\/wp\/v2\/media?parent=3308"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/rythmologie.fr\/index\/wp-json\/wp\/v2\/categories?post=3308"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/rythmologie.fr\/index\/wp-json\/wp\/v2\/tags?post=3308"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}