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

Xiao-dong Zhuang

Status and phase: Not yet enrolling; Phase 4

Conditions: Left Bundle Branch Block; Transcatheter Aortic Valve Replacemen

Treatments: Drug: Placebo; Drug: Methylprednisolone (Corticosteroid)

Study type: Interventional

Funder types: Other

Identifiers

NCT06762145

82070384 (Other Grant/Funding Number)

ChiCTR 200039901

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups, including a placebo group

Methylprednisolone

Experimental group

Treatment:

Drug: Methylprednisolone (Corticosteroid)

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo