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

Phase 4Not Yet RecruitingNCT06762145

Xiao-dong Zhuang200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

200

Conditions

Transcatheter Aortic Valve Replacemen Left Bundle Branch Block

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age ≥ 65 years 2. Selected to undergo transfemoral TAVR based on heart team decision Exclusion Criteria: 1. Allergic to Methylprednisolone 2. Patients with a prior pacemaker or high degree atrioventricular block 3. Septicemia 4. Life expectancy \< 1 year irrespective of heart disease (Cancer, severe liver disease, severe renal disease, severe pulmonary, et al) 5. Inability to provide written informed consent 6. Participation in another clinical trial with an active intervention 7. Patients on prior chronic treatment with glucocorticoids (both oral, inhaled, or intravenous, but topical and ophthalmic administration is allowed) 8. Gastrointestinal bleeding 9. Acute myocardial infarction within 1 month 10. Intracardiac thrombus or vegetation

Outcomes

Primary Outcomes

Incidence rate of persistent LBBB

Assessed based on electrocardiogram performed at admission, every day post TAVR until discharge. New-onset LBBB is defined as LBBB with no RBBB before the procedure and high degree atrioventricular block with RBBB before the procedure. Persistent LBBB is defined as present LBBB at discharge or \>7 days post-TAVR.

Time frame: 30 days

Secondary Outcomes

Occurrence of permanent LBBB

Present LBBB \>30 days post-TAVR

Time frame: 1 year

Occurrence of syncope

Assessed based on symptoms