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| ID | Type | Description | Link |
|---|---|---|---|
| 82070384 | Other Grant/Funding Number | National Natural Science Foundation of China |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methylprednisolone | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylprednisolone (Corticosteroid) | Drug | Intravenous Methylprednisolone 1mg/kg/d for 3 days started from the day on TAVR |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of persistent LBBB | 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. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of permanent LBBB | Present LBBB >30 days post-TAVR | 1 year |
| Occurrence of syncope | Assessed based on symptoms | 30 days and 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Outcome | Incidence of clinically severe side effects possibly related to study drug intake like infection, gastrointestinal bleeding. | 30 days and 1 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaodong Zhuang, MD | Contact | +8613760755035 | zhuangxd3@mail.sysu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong | 510080 | China |
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| Placebo | Drug | Placebo for 3 days started from the day on TAVR |
|
| Incidence of permanent pacemaker implantation | Assessed based on operation history | 30 days and 1 year |
| Rehospitalization rate | According to medical history or telephone follow-ups | 30 days and 1 year |
| The changes of left ventricular ejection fraction | Evaluated based on echocardiogram | 30 days and 1 year |
| The incidences of major clinical adverse events | All-cause mortality, cardiovascular mortality, stroke, myocardial infarction | 30 days and 1 year |
| ID | Term |
|---|---|
| D002037 | Bundle-Branch Block |
| ID | Term |
|---|---|
| D006327 | Heart Block |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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