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

Phase 4

Not yet recruiting

• Conditions: Transcatheter Aortic Valve Replacemen; Left Bundle Branch Block
• Interventions: Drug: Methylprednisolone (Corticosteroid); Drug: Placebo

• Registration Number: NCT06762145
• Lead Sponsor: Xiao-dong Zhuang

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study Start: 2025-01-01
• Study First Submitted: 2025-01-01
• Study First Submitted QC: 2025-01-01
• Last Update Submitted: 2025-01-01
• Study First Posted: 2025-01-07
• Last Update Posted: 2025-01-07
• Primary Completion: 2025-06-30
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Methylprednisolone	Methylprednisolone (Corticosteroid)	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Incidence rate of persistent LBBB	30 days	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.

Secondary Outcome Measures

Name	Time	Method
Occurrence of permanent LBBB	1 year	Present LBBB \>30 days post-TAVR
Occurrence of syncope	30 days and 1 year	Assessed based on symptoms
Incidence of permanent pacemaker implantation	30 days and 1 year	Assessed based on operation history
Rehospitalization rate	30 days and 1 year	According to medical history or telephone follow-ups
The changes of left ventricular ejection fraction	30 days and 1 year	Evaluated based on echocardiogram
The incidences of major clinical adverse events	30 days and 1 year	All-cause mortality, cardiovascular mortality, stroke, myocardial infarction

Trial Locations

Locations (1)

The First Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China