A Phase 4 interventional study of Methylprednisolone (Corticosteroid) and Placebo in Transcatheter Aortic Valve Replacemen and Left Bundle Branch Block, sponsored by Xiao-dong Zhuang. Not yet recruiting at 1 site in China. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-01-07.
Sponsored by Xiao-dong Zhuang · Phase 4, Interventional, and Prevention
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.
94 studies on the registry are indexed under Bundle-Branch Block; 30 are open to participants now.
This study's planned enrollment of 200 is above the median of 60 across 59 interventional studies indexed under Bundle-Branch Block.
Browse Bundle-Branch Block studies →Xiao-dong Zhuang is the lead sponsor of 7 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Methylprednisolone (Corticosteroid)
Drug: Placebo
Intravenous Methylprednisolone 1mg/kg/d for 3 days started from the day on TAVR
Placebo for 3 days started from the day on TAVR
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.
Time frame: 30 days
Occurrence of permanent LBBB
Present LBBB \>30 days post-TAVR
Time frame: 1 year
Occurrence of syncope
Assessed based on symptoms
Time frame: 30 days and 1 year
Incidence of permanent pacemaker implantation
Assessed based on operation history
Time frame: 30 days and 1 year
Rehospitalization rate
According to medical history or telephone follow-ups
Time frame: 30 days and 1 year
The changes of left ventricular ejection fraction
Evaluated based on echocardiogram
Time frame: 30 days and 1 year
The incidences of major clinical adverse events
All-cause mortality, cardiovascular mortality, stroke, myocardial infarction
Time frame: 30 days and 1 year
Safety Outcome
Incidence of clinically severe side effects possibly related to study drug intake like infection, gastrointestinal bleeding.
Time frame: 30 days and 1 year
Plan to share: No
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This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Methylprednisolone
Xiao-dong Zhuang