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

NCT ID: NCT06762145

Last Updated: 2025-01-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2025-07-31

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.

Conditions

Transcatheter Aortic Valve Replacemen; Left Bundle Branch Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Methylprednisolone

Group Type: EXPERIMENTAL

Methylprednisolone (Corticosteroid)

Intervention Type: DRUG

Intravenous Methylprednisolone 1mg/kg/d for 3 days started from the day on TAVR

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo for 3 days started from the day on TAVR

Interventions

Methylprednisolone (Corticosteroid)

Intravenous Methylprednisolone 1mg/kg/d for 3 days started from the day on TAVR

Intervention Type: DRUG

Placebo

Placebo for 3 days started from the day on TAVR

Intervention Type: DRUG

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xiao-dong Zhuang

OTHER

Sponsor Role: lead

Responsible Party

Xiao-dong Zhuang

Dr.

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Countries

China

Central Contacts

Xiaodong Zhuang, MD

Role: CONTACT

zhuangxd3@mail.sysu.edu.cn

+8613760755035

Facility Contacts

Xiaojie Cai, MD

Role: primary

caixj28@mail.sysu.edu.cn

+8618392887097

Other Identifiers

82070384

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

ChiCTR 200039901

Identifier Type: -

Identifier Source: org_study_id