{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,10]],"date-time":"2026-09-10T10:03:56Z","timestamp":1789034636683,"version":"build-2803163510"},"reference-count":25,"publisher":"BMJ","issue":"10","funder":[{"DOI":"10.13039\/501100005035","name":"Biotronik","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100005035","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2016,1,28]]},"published-print":{"date-parts":[[2016,10]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Percutaneous aortic valve replacement (transcatheter aortic valve implantation (TAVI)) notably increases the likelihood of the appearance of a complete left bundle branch block (LBBB) by direct lesion of the LBB of His. This block can lead to high-grade atrioventricular conduction disturbances responsible for a poorer prognosis. The management of this complication remains controversial.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Method and analysis<\/jats:title>\n                    <jats:p>The screening of LBBB after TAVI persisting for more than 24\u2005hours will be conducted by surface ECG. Stratification will be performed by post-TAVI intracardiac electrophysiological study. Patients at high risk of conduction disturbances (\u226570\u2005ms His\u2013ventricle interval (HV) or presence of infra-Hisian block) will be implanted with a pacemaker enabling the recording of disturbance episodes. Those at lower risk (HV &lt;70\u2005ms) will be implanted with a loop recorder device with remote monitoring of cardiovascular implantable electronic devices (CIEDs). Clinical, ECG and implanted device follow-up will also be performed at 3, 6 and 12\u2005months. The primary objective is to assess the efficacy and safety of a decisional algorithm based on electrophysiological study and remote monitoring of CIEDs in the prediction of high-grade conduction disturbances in patients with LBBB after TAVI. The primary end point is to compare the incidence (rate and time to onset) of high-grade conduction disturbances in patients with LBBB after TAVI between the two groups at 12\u2005months. Given the proportion of high-grade conduction disturbances (20\u201340%), a sample of 200 subjects will allow a margin of error of 6\u20137%. The LBBB\u2013TAVI Study has been in an active recruiting phase since September 2015 (21 patients already included).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>Local ethics committee authorisation was obtained in May 2015. We will publish findings from this study in a peer-reviewed scientific journal and present results at national and international conferences.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>NCT02482844; Pre-results.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2015-010485","type":"journal-article","created":{"date-parts":[[2016,10,26]],"date-time":"2016-10-26T22:59:32Z","timestamp":1477522772000},"page":"e010485","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":22,"title":["Prognosis assessment of persistent left bundle branch block after TAVI by an electrophysiological and remote monitoring risk-adapted algorithm: rationale and design of the multicentre LBBB\u2013TAVI 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