About this trial
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.
Eligibility criteria
Qualifiers
Age ≥ 65 years
Selected to undergo transfemoral TAVR based on heart team decision
Disqualifiers
Allergic to Methylprednisolone
Patients with a prior pacemaker or high degree atrioventricular block
Septicemia
Life expectancy < 1 year irrespective of heart disease (Cancer, severe liver disease, severe renal disease, severe pulmonary, et al)
Trial design
Treatments tested in this trial
- Methylprednisolone (Corticosteroid)
- Placebo
Treatment groups
Sponsors and collaborators
Xiao-dong Zhuang
Lead sponsor
Sun Yat-sen University
Sponsor institution