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

NCT06762145 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: ChiCTR 20003990182070384
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Transcatheter Aortic Valve Replacemen; Left Bundle Branch Block

Keywords

TAVR; LBBB; Glucocorticoid

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Occurrence of permanent LBBB

  1 year

• Occurrence of syncope

  30 days and 1 year

• Incidence of permanent pacemaker implantation

  30 days and 1 year

• Rehospitalization rate

  30 days and 1 year

• The changes of left ventricular ejection fraction

  30 days and 1 year

Other Outcomes (1)

• Safety Outcome

  30 days and 1 year

Study Arms (2)

Methylprednisolone

EXPERIMENTAL

Drug: Methylprednisolone (Corticosteroid)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Methylprednisolone (Corticosteroid) DRUG

Intravenous Methylprednisolone 1mg/kg/d for 3 days started from the day on TAVR

Methylprednisolone

Placebo DRUG

Placebo for 3 days started from the day on TAVR

Placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥ 65 years
• Selected to undergo transfemoral TAVR based on heart team decision

You may not qualify if:

• 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)
• Inability to provide written informed consent
• Participation in another clinical trial with an active intervention
• Patients on prior chronic treatment with glucocorticoids (both oral, inhaled, or intravenous, but topical and ophthalmic administration is allowed)
• Gastrointestinal bleeding
• Acute myocardial infarction within 1 month
• Intracardiac thrombus or vegetation

Sponsors & Collaborators

• Xiao-dong Zhuang: lead

Study Sites (1)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Bundle-Branch Block

Interventions

Methylprednisolone; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Heart Block; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Xiaodong Zhuang, MD

CONTACT

+8613760755035; zhuangxd3@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: January 1, 2025
• First Posted: January 7, 2025
• Study Start: January 1, 2025
• Primary Completion: June 30, 2025
• Study Completion: July 31, 2025
• Last Updated: January 7, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)