NCT06762145

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

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Xiao-dong Zhuang · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Transcatheter Aortic Valve Replacemen
• Left Bundle Branch Block

Interventions

Type	Name	Description
DRUG	Methylprednisolone (Corticosteroid)	Intravenous Methylprednisolone 1mg/kg/d for 3 days started from the day on TAVR
DRUG	Placebo	Placebo for 3 days started from the day on TAVR

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-06-30
• Completion: 2025-07-31
• First posted: 2025-01-07
• Last updated: 2025-01-07

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study