EArly Effect of Glucocorticoid on Incidence of Persistent Left BundlE Branch Block (LBBB) Post-TAVR (EAGLE-TAVR Trial)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Methylprednisolone (Corticosteroid), Placebo.
- Who it may be relevant to
- Registry conditions: Transcatheter Aortic Valve Replacemen, Left Bundle Branch Block. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
EArly Effect of Glucocorticoid on Incidence of Persistent Left BundlE Branch Block (LBBB) Post-TAVR
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.
Interventions
- Drug Methylprednisolone (Corticosteroid)
Intravenous Methylprednisolone 1mg/kg/d for 3 days started from the day on TAVR - Drug Placebo
Placebo for 3 days started from the day on TAVR
Primary outcome measures
- Incidence rate of persistent LBBB [Time frame: 30 days]
Secondary outcome measures (6)
- Occurrence of permanent LBBB [Time frame: 1 year]
- Occurrence of syncope [Time frame: 30 days and 1 year]
- Incidence of permanent pacemaker implantation [Time frame: 30 days and 1 year]
- Rehospitalization rate [Time frame: 30 days and 1 year]
- The changes of left ventricular ejection fraction [Time frame: 30 days and 1 year]
- The incidences of major clinical adverse events [Time frame: 30 days and 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
China · 1 center
- The First Affiliated Hospital of Sun Yat-sen University — Guangzhou
Identifiers
NCT: NCT06762145 · ChiCTR 200039901 · 82070384