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

Launched by XIAO-DONG ZHUANG · Jan 1, 2025

Keywords

ClinConnect Summary

The EAGLE-TAVR trial is a study designed to see if a medication called Methylprednisolone can help prevent a common complication called persistent left bundle branch block (LBBB) after a procedure known as Transcatheter Aortic Valve Replacement (TAVR). TAVR is a treatment for patients with severe aortic stenosis, a condition where the heart's aortic valve narrows and makes it hard for blood to flow. In this trial, 200 patients aged 65 and older who are scheduled for TAVR will be randomly assigned to receive either Methylprednisolone or a placebo (a harmless substitute) for three days starting on the day of their procedure.

Participants in this trial can expect close monitoring for any new heart rhythm issues, specifically LBBB, for 30 days after their TAVR procedure. To be eligible, patients must be at least 65 years old and approved for TAVR by their healthcare team. However, those with certain health conditions, such as allergies to the medication, a prior pacemaker, or serious illnesses with a short life expectancy, will not be able to participate. This trial is important because if the medication is effective, it could improve heart health outcomes for patients undergoing TAVR.

Gender

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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