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

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

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 Overview

• Status: Not yet recruiting
• Conditions: Left Bundle Branch Block; Transcatheter Aortic Valve Replacemen
• Intervention / Treatment: Drug: Methylprednisolone (Corticosteroid); Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Xiaodong Zhuang, MD; Phone Number: +8613760755035; Email: zhuangxd3@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • The First Affiliated Hospital of Sun Yat-Sen University
      • Contact: Xiaojie Cai, MD; Phone Number: +8618392887097; Email: caixj28@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo for 3 days started from the day on TAVR
Experimental: Methylprednisolone	Drug: Methylprednisolone (Corticosteroid); Intravenous Methylprednisolone 1mg/kg/d for 3 days started from the day on TAVR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Outcome	Incidence of clinically severe side effects possibly related to study drug intake like infection, gastrointestinal bleeding.	30 days and 1 year

Collaborators and Investigators

• Sponsor: Xiao-dong Zhuang

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: January 1, 2025
• First Submitted That Met QC Criteria: January 1, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 1, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: TAVR; Glucocorticoid; LBBB
• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Bundle-Branch Block; Heart Block; Antineoplastic Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protective Agents; Neuroprotective Agents; Methylprednisolone Acetate; Prednisolone; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
• Other Study ID Numbers: ChiCTR 200039901; 82070384 (Other Grant/Funding Number: National Natural Science Foundation of China)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes