Clinical Research Directory

EArly Effect of Glucocorticoid on Incidence of Persistent Left BundlE Branch Block (LBBB) Post-TAVR (EAGLE-TAVR Trial)

Sponsor: Xiao-dong Zhuang

Summary

Transcatheter aortic valve replacement (TAVR) has become an established alternative for the treatment of severe symptomatic aortic stenosis irrespective of surgical risk. The development of new-onset left bundle branch block (LBBB) is the most common complication, which impairs outcomes after TAVR. Glucocorticoid has been proven safe and effective in arrythmia after cardiac surgery. The anti-inflammatory effect of glucocorticoid may alleviate the occurrence of LBBB and thus the prognosis. EAGLE-TAVR is a multi-center, randomized, double blind, placebo-controlled trial. A total of 200 patients selected to undergo TAVR will be randomized in a 1:1 ratio to the treatment with intravenous Methylprednisolone 1mg/kg/day or placebo for 3 days started from the day of the procedure. According to the definition of the Valve Academic Research Consortium 3, persistent LBBB is defined as present LBBB at discharge or \>7 days post-TAVR. The primary endpoint is the occurrence of new-onset LBBB at 30 days post TAVR.

Official title: EArly Effect of Glucocorticoid on Incidence of Persistent Left BundlE Branch Block (LBBB) Post-TAVR

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