EArly Effect of Glucocorticoid on Incidence of Persistent Left BundlE Branch Block (LBBB) Post-TAVR (EAGLE-TAVR Trial)
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age65+
SponsorXiao-dong Zhuang
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 65 years
Selected to undergo transfemoral TAVR based on heart team decision
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Methylprednisolone (Corticosteroid)
DrugIntravenous Methylprednisolone 1mg/kg/d for 3 days started from the day on TAVR
Placebo
DrugPlacebo for 3 days started from the day on TAVR
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: MethylprednisoloneExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
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.
Time frame
30 daysSecondary outcomes
1
Occurrence of permanent LBBB
Present LBBB \>30 days post-TAVR
Time frame
1 year2
Occurrence of syncope
Assessed based on symptoms
Time frame
30 days and 1 year3
Incidence of permanent pacemaker implantation
Assessed based on operation history
Time frame
30 days and 1 year4
Rehospitalization rate
According to medical history or telephone follow-ups
Time frame
30 days and 1 yearOther outcomes
1
Safety Outcome
Incidence of clinically severe side effects possibly related to study drug intake like infection, gastrointestinal bleeding.
Time frame
30 days and 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Xiao-dong Zhuang
Lead sponsor
Sun Yat-sen University
Sponsor institution
Source ClinicalTrials.gov
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