Left Atrial Appendage ClosureNCT07382362
Preventing Neurologic Complications in Valve Surgery
An observational study of Left Atrial Appendage Closure, run by China National Center for Cardiovascular Diseases at 4 sites in China.
Trial summary
In patients with valvular heart disease and atrial fibrillation (AF) undergoing surgical valve surgery, current guidelines recommend concomitant surgical management of the left atrial appendage (LAA) to prevent postoperative thromboembolic events, particularly neurologic embolic events. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Left Atrial Appendage Closure
- What is being tested?
- Left Atrial Appendage (LAA) Suture Closure and Surgical Valve Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 4 sitesChina
- Study dates
- 27 Jan 2026to 31 Jul 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is a multicenter observational study conducted at four participating hospitals in China. Adult patients (≥18 years) without atrial fibrillation who are scheduled to undergo elective open surgical heart valve surgery and provide informed consent will be enrolled. Participants will be grouped according to whether concomitant left atrial appendage (LAA) suture closure is performed during the index operation. The primary outcome is perioperative silent brain infarction (SBI) assessed by brain MRI at approximately postoperative day 5. Secondary outcomes include stroke, myocardial infarction, all-cause death, cardiovascular death, and MACCE within 30 days after surgery, as well as SBI and MACCE (including rehospitalization for heart failure) within 1 year after surgery.
Who may be able to join
- Adult patients (≥18 years) without atrial fibrillation who are scheduled to undergo open (direct-vision) surgical heart valve surgery and who are informed about the study and provide written informed consent to participate.
Who cannot join
- History of prior cardiac surgery
- history of cerebral infarction (ischemic stroke)
- emergency surgery
- infective endocarditis
- pregnancy
- refusal or inability to provide informed consent/declines participation in this study.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites
Fuwai Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality
LIANXIN Chen, 01088322265, chenlianx1@163.com
Peking University First Hospita
Beijing, Beijing Municipality
Wang, 13522784537, wj0463@sina.cn
Qingdao Cardiovascular Hospital
Qingdao
Feng, 13964265680, fengzunyi@163.com
Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen
Shenzhen
Nie, 13701176101, wangsymd@126.com
About this study
Official title: Strategies for the Prevention of Perioperative Neurological Complications in Cardiac Valve Surgery
In patients with valvular heart disease and atrial fibrillation (AF) undergoing surgical valve surgery, current guidelines recommend concomitant surgical management of the left atrial appendage (LAA) to prevent postoperative thromboembolic events, particularly neurologic embolic events. However, whether concomitant LAA management benefits patients without AF by reducing postoperative neurologic complications remains controversial.
Given these uncertainties, this study aims to evaluate whether concomitant LAA suture closure during surgical valve surgery is associated with a lower incidence of perioperative silent cerebral infarction.
- Conditions
- Left Atrial Appendage Closure
- Being tested
- Left Atrial Appendage (LAA) Suture Closure, Surgical Valve Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left Atrial Appendage (LAA) Suture ClosureProcedure or surgery
Concomitant suture closure of the LAA performed at the time of surgical valve surgery, at the discretion of the operating surgeon.
Surgical Valve SurgeryProcedure or surgery
Standard surgical valve repair or replacement performed according to routine clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Valve surgery with concomitant LAA suture closure | Concomitant suture closure of the LAA performed during surgical valve surgery. Receives: Procedure: Left Atrial Appendage (LAA) Suture Closure | |
| Valve surgery alone (no LAA procedure) | Standard surgical valve surgery without concomitant LAA suture closure. Receives: Procedure: Surgical Valve Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Silent brain infarction (SBI)
Occurrence of SBI assessed by postoperative brain magnetic resonance imaging (MRI) performed at approximately postoperative day 5.
Measured: Approximately postoperative day 5
Secondary outcomes (5)
Perioperative stroke
Incidence of clinically overt stroke within 30 days after surgery.
Measured: Within 30 days after surgery
Perioperative all-cause mortality
Death from any cause within 30 days after surgery.
Measured: Within 30 days after surgery
Perioperative MACCE
Incidence of major adverse cardiovascular and cerebrovascular events (MACCE), defined as a composite of stroke, myocardial infarction, all-cause death, or cardiovascular death occurring within 30 days after surgery.
Measured: Within 30 days after surgery
Silent brain infarction (SBI) at 1 year
1 year after surgery
Measured: Occurrence of SBI assessed by brain MRI at 1 year after surgery.
MACCE at 1 year
Incidence of major adverse cardiovascular and cerebrovascular events (MACCE) within 1 year after surgery, defined as a composite of stroke, myocardial infarction, all-cause death, cardiovascular death, or rehospitalization for heart failure.
Measured: Within 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start27 Jan 2026 (estimated)
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Atrial Appendage ClosureStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- China National Center for Cardiovascular Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07382362
- Sponsor's protocol ID
- 2024-2452
- Status last verified
- Jan 2026
- First submitted
- 25 Jan 2026
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategies for the Prevention of Perioperative Neurological Complications in Cardiac Valve Surgery
- ClinicalTrials.gov ID
- NCT07382362
- Acronym / sponsor ID
- 2024-2452
- Conditions
- Left Atrial Appendage Closure
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 27 Jan 2026 (estimated)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 2 Feb 2026 (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.
In patients with valvular heart disease and atrial fibrillation (AF) undergoing surgical valve surgery, current guidelines recommend concomitant surgical management of the left atrial appendage (LAA) to prevent postoperative thromboembolic events, particularly neurologic embolic events. However, whether concomitant LAA management benefits patients without AF by reducing postoperative neurologic complications remains controversial.
Given these uncertainties, this study aims to evaluate whether concomitant LAA suture closure during surgical valve surgery is associated with a lower incidence of perioperative silent cerebral infarction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Valve surgery with concomitant LAA suture closure | – | Procedure: Left Atrial Appendage (LAA) Suture ClosureConcomitant suture closure of the LAA performed during surgical valve surgery. |
| Valve surgery alone (no LAA procedure) | – | Procedure: Surgical Valve SurgeryStandard surgical valve surgery without concomitant LAA suture closure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a multicenter observational study conducted at four participating hospitals in China. Adult patients (≥18 years) without atrial fibrillation who are scheduled to undergo elective open surgical heart valve surgery and provide informed consent will be enrolled. Participants will be grouped according to whether concomitant left atrial appendage (LAA) suture closure is performed during the index operation. The primary outcome is perioperative silent brain infarction (SBI) assessed by brain MRI at approximately postoperative day 5. Secondary outcomes include stroke, myocardial infarction, all-cause death, cardiovascular death, and MACCE within 30 days after surgery, as well as SBI and MACCE (including rehospitalization for heart failure) within 1 year after surgery.
Key inclusion criteria (1 listed)
- Adult patients (≥18 years) without atrial fibrillation who are scheduled to undergo open (direct-vision) surgical heart valve surgery and who are informed about the study and provide written informed consent to participate.
Key exclusion criteria (6 listed)
- History of prior cardiac surgery
- history of cerebral infarction (ischemic stroke)
- emergency surgery
- infective endocarditis
- pregnancy
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 |
|---|---|---|
| Left Atrial Appendage (LAA) Suture ClosureConcomitant suture closure of the LAA performed at the time of surgical valve surgery, at the discretion of the operating surgeon. | Procedure or surgery | Valve surgery with concomitant LAA suture closure |
| Surgical Valve SurgeryStandard surgical valve repair or replacement performed according to routine clinical practice. | Procedure or surgery | Valve surgery alone (no LAA procedure) |
Primary outcome
Silent brain infarction (SBI)
Time frame: Approximately postoperative day 5
Occurrence of SBI assessed by postoperative brain magnetic resonance imaging (MRI) performed at approximately postoperative day 5.
5 secondary outcomes
Perioperative stroke
Time frame: Within 30 days after surgery
Perioperative all-cause mortality
Time frame: Within 30 days after surgery
Perioperative MACCE
Time frame: Within 30 days after surgery
Silent brain infarction (SBI) at 1 year
Time frame: Occurrence of SBI assessed by brain MRI at 1 year after surgery.
MACCE at 1 year
Time frame: Within 1 year after surgery
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 2 Feb 2026.
- Individual participant dataSharing planned: No
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Left Atrial Appendage Closure, run by China National Center for Cardiovascular Diseases at 4 sites 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 1 inclusion and 6 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 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 LIANXIN Chen (01088322265, chenlianx1@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Silent brain infarction (SBI) (time frame: Approximately postoperative day 5). 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 2 Feb 2026; AzTrials last refreshed its copy on 31 Oct 2026.