Transcatheter Aortic Valve ReplacemenPhase 4EAGLE-TAVRNCT06762145
EArly Effect of Glucocorticoid on Incidence of Persistent Left BundlE Branch Block (LBBB) Post-TAVR (EAGLE-TAVR Trial)
A Phase 4 study testing Methylprednisolone (Corticosteroid) in people with Transcatheter Aortic Valve Replacemen and Left Bundle Branch Block, run by Xiao-dong Zhuang at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Transcatheter Aortic Valve Replacemen, Left Bundle Branch Block
- What is being tested?
- Methylprednisolone (Corticosteroid)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 31 Jul 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥ 65 years
- Selected to undergo transfemoral TAVR based on heart team decision
Who cannot join
- Allergic to Methylprednisolone
- Patients with a prior pacemaker or high degree atrioventricular block
- Septicemia
- Life expectancy < 1 year irrespective of heart disease (Cancer, severe liver disease, severe renal disease, severe pulmonary, et al)
- Inability to provide written informed consent
- Participation in another clinical trial with an active intervention
Show all 10Show fewer
- Patients on prior chronic treatment with glucocorticoids (both oral, inhaled, or intravenous, but topical and ophthalmic administration is allowed)
- Gastrointestinal bleeding
- Acute myocardial infarction within 1 month
- Intracardiac thrombus or vegetation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080
Xiaojie Cai, MD, +8618392887097, caixj28@mail.sysu.edu.cn
About this study
Official title: EArly Effect of Glucocorticoid on Incidence of Persistent Left BundlE Branch Block (LBBB) Post-TAVR
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.
Read more
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.
- Being tested
- Methylprednisolone (Corticosteroid), Placebo
- Keywords
- TAVR, LBBB, Glucocorticoid
- Medical subject headings
- Bundle-Branch Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylprednisolone (Corticosteroid)Drug
Intravenous Methylprednisolone 1mg/kg/d for 3 days started from the day on TAVR
PlaceboDrug
Placebo for 3 days started from the day on TAVR
| Study group | Role | What they receive |
|---|---|---|
| Methylprednisolone | Experimental | Not described Receives: Drug: Methylprednisolone (Corticosteroid) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (6)
Occurrence of permanent LBBB
Present LBBB >30 days post-TAVR
Measured: 1 year
Occurrence of syncope
Assessed based on symptoms
Measured: 30 days and 1 year
Incidence of permanent pacemaker implantation
Assessed based on operation history
Measured: 30 days and 1 year
Rehospitalization rate
According to medical history or telephone follow-ups
Measured: 30 days and 1 year
The changes of left ventricular ejection fraction
Evaluated based on echocardiogram
Measured: 30 days and 1 year
The incidences of major clinical adverse events
All-cause mortality, cardiovascular mortality, stroke, myocardial infarction
Measured: 30 days and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start1 Jan 2025 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcatheter Aortic Valve ReplacemenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiao-dong Zhuang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiao-dong Zhuang, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06762145
- Sponsor's protocol ID
- ChiCTR 200039901
- Other IDs
- 82070384
- Acronym
- EAGLE-TAVR
- Status last verified
- Dec 2024
- First submitted
- 1 Jan 2025
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EArly Effect of Glucocorticoid on Incidence of Persistent Left BundlE Branch Block (LBBB) Post-TAVR
- ClinicalTrials.gov ID
- NCT06762145
- Acronym / sponsor ID
- EAGLE-TAVR / ChiCTR 200039901
- Keywords
- TAVR, LBBB, Glucocorticoid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Xiao-dong ZhuangUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 7 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methylprednisolone | Experimental | Drug: Methylprednisolone (Corticosteroid) |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Age ≥ 65 years
- Selected to undergo transfemoral TAVR based on heart team decision
Key exclusion criteria (10 listed)
- Allergic to Methylprednisolone
- Patients with a prior pacemaker or high degree atrioventricular block
- Septicemia
- Life expectancy < 1 year irrespective of heart disease (Cancer, severe liver disease, severe renal disease, severe pulmonary, et al)
- Inability to provide written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methylprednisolone (Corticosteroid)Intravenous Methylprednisolone 1mg/kg/d for 3 days started from the day on TAVR | Drug | Methylprednisolone |
| PlaceboPlacebo for 3 days started from the day on TAVR | Drug | Placebo |
Primary outcome
Incidence rate of persistent LBBB
Time frame: 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.
6 secondary outcomes
Occurrence of permanent LBBB
Time frame: 1 year
Occurrence of syncope
Time frame: 30 days and 1 year
Incidence of permanent pacemaker implantation
Time frame: 30 days and 1 year
Rehospitalization rate
Time frame: 30 days and 1 year
The changes of left ventricular ejection fraction
Time frame: 30 days and 1 year
The incidences of major clinical adverse events
Time frame: 30 days and 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Transcatheter Aortic Valve Replacemen
RecruitingObservational study
Echocardiography Guided TAVR (Echo TAVR)
Transcatheter Aortic Valve Replacemen, Echocardiography
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methylprednisolone (Corticosteroid) in people with Transcatheter Aortic Valve Replacemen and Left Bundle Branch Block, run by Xiao-dong Zhuang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaodong Zhuang, MD (+8613760755035, zhuangxd3@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of persistent LBBB (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.