Transcatheter Aortic Valve Replacemen, Left Bundle Branch Block
Conditions
Keywords
TAVR, LBBB, Glucocorticoid
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.
Interventions
Intravenous Methylprednisolone 1mg/kg/d for 3 days started from the day on TAVR
DRUGPlacebo
Placebo for 3 days started from the day on TAVR
Sponsors
Xiao-dong Zhuang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence rate of persistent LBBB | 30 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of permanent pacemaker implantation | 30 days and 1 year | Assessed based on operation history |
| Rehospitalization rate | 30 days and 1 year | According to medical history or telephone follow-ups |
| The changes of left ventricular ejection fraction | 30 days and 1 year | Evaluated based on echocardiogram |
| Occurrence of permanent LBBB | 1 year | Present LBBB \>30 days post-TAVR |
| Occurrence of syncope | 30 days and 1 year | Assessed based on symptoms |
| The incidences of major clinical adverse events | 30 days and 1 year | All-cause mortality, cardiovascular mortality, stroke, myocardial infarction |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety Outcome | 30 days and 1 year | Incidence of clinically severe side effects possibly related to study drug intake like infection, gastrointestinal bleeding. |
Countries
China
Contacts
Primary ContactXiaodong Zhuang, MD
Outcome results
None listed