Clinical trial NCT06762145: EArly Effect of Glucocorticoid on Incidence of Persistent Left BundlE Branch Block (LBBB) Post-TAVR (EAGLE-TAVR Trial)
Official title: EArly Effect of Glucocorticoid on Incidence of Persistent Left BundlE Branch Block (LBBB) Post-TAVR
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Transcatheter Aortic Valve Replacemen
Left Bundle Branch Block
Keywords: TAVR
LBBB
Glucocorticoid
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2025-01-07
Enrollment: 200
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 65 years
2. Selected to undergo transfemoral TAVR based on heart team decision

Exclusion Criteria:

1. Allergic to Methylprednisolone
2. Patients with a prior pacemaker or high degree atrioventricular block
3. Septicemia
4. Life expectancy \< 1 year irrespective of heart disease (Cancer, severe liver disease, severe renal disease, severe pulmonary, et al)
5. Inability to provide written informed consent
6. Participation in another clinical trial with an active intervention
7. Patients on prior chronic treatment with glucocorticoids (both oral, inhaled, or intravenous, but topical and ophthalmic administration is allowed)
8. Gastrointestinal bleeding
9. Acute myocardial infarction within 1 month
10. Intracardiac thrombus or vegetation

Primary outcomes:
measure: Incidence rate of persistent LBBB
timeFrame: 30 days
Secondary outcomes:
measure: Occurrence of permanent LBBB
timeFrame: 1 year
measure: Occurrence of syncope
timeFrame: 30 days and 1 year
measure: Incidence of permanent pacemaker implantation
timeFrame: 30 days and 1 year
measure: Rehospitalization rate
timeFrame: 30 days and 1 year
measure: The changes of left ventricular ejection fraction
timeFrame: 30 days and 1 year
measure: The incidences of major clinical adverse events
timeFrame: 30 days and 1 year
Other outcomes:
measure: Safety Outcome
timeFrame: 30 days and 1 year
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
References: