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NCT Number: NCT06762145

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

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.

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Key information

Conditions

Transcatheter Aortic Valve Replacemen Arrhythmias, Cardiac Bundle-Branch Block Cardiac Conduction System Disease Cardiovascular Diseases Heart Block Heart Diseases Left Bundle Branch Block Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location contact

Xiaojie Cai, MD

CONTACT

[email protected]

+8618392887097

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Methylprednisolone (Corticosteroid)

Drug

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

Placebo

Drug

Placebo for 3 days started from the day on TAVR

Primary outcomes

  1. Incidence rate of persistent LBBB

    Time frame: 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 outcomes

  1. Occurrence of permanent LBBB

    Time frame: 1 year

    Present LBBB >30 days post-TAVR

  2. Occurrence of syncope

    Time frame: 30 days and 1 year

    Assessed based on symptoms

  3. Incidence of permanent pacemaker implantation

    Time frame: 30 days and 1 year

    Assessed based on operation history

  4. Rehospitalization rate

    Time frame: 30 days and 1 year

    According to medical history or telephone follow-ups

  5. The changes of left ventricular ejection fraction

    Time frame: 30 days and 1 year

    Evaluated based on echocardiogram

  6. The incidences of major clinical adverse events

    Time frame: 30 days and 1 year

    All-cause mortality, cardiovascular mortality, stroke, myocardial infarction

Other outcomes

  1. Safety Outcome

    Time frame: 30 days and 1 year

    Incidence of clinically severe side effects possibly related to study drug intake like infection, gastrointestinal bleeding.

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaodong Zhuang, MD

CONTACT

[email protected]

+8613760755035

Sponsors and collaborators

Lead sponsor

Xiao-dong Zhuang

Other

Registry information

Official study title

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

Acronym: EAGLE-TAVR

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 7, 2025
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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