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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age65+
SponsorXiao-dong Zhuang

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

200 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Xiao-dong Zhuang

Lead sponsor

Sun Yat-sen University

Sponsor institution