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Randomized Controlled Clinical Study Protocol for the Concurrent Application of Left Atrial Appendage Clip During Coronary Artery Bypass Grafting to Prevent Postoperative Atrial Fibrillation and Stroke

Randomized Controlled Clinical Study Protocol for the Concurrent Application of Left Atrial Appendage Clip During Coronary Artery Bypass Grafting to Prevent Postoperative Atrial Fibrillation and Stroke

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500114403
Enrollment
Unknown
Registered
2025-12-11
Start date
2026-01-01
Completion date
Unknown
Last updated
2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

New-onset atrial fibrillation after CABG

Interventions

Control group:Coronary Artery Bypass Grafting (CABG)
Test group:Concomitant left atrial appendage clip closure during coronary artery bypass grafting

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years, regardless of gender; 2. Preoperative sinus rhythm confirmed by electrocardiogram or Holter monitoring; 3. Meets the indications for CABG surgery (according to the 2023 ESC Guidelines for the Management of Coronary Artery Disease); 4. CHA2DS2-VASc score >= 2; 5. Preoperative cardiac ultrasound indicates a left atrial appendage volume 50 ml may have suboptimal closure outcomes and are excluded); 6. American Society of Anesthesiologists (ASA) classification II-III (patients with ASA IV are excluded due to excessively high surgical risk); 7. The patient and their family have been informed and provided signed informed consent, agreeing to complete a 1-year follow-up.

Exclusion criteria

Exclusion criteria: 1. History of prior cardiac surgery; 2. Preoperative history of atrial fibrillation (including paroxysmal, persistent, or permanent AF) or preoperative Holter monitoring indicating an AF burden > 5%; 3. Preoperative diagnosis of stroke (including ischemic or hemorrhagic stroke) or transient ischemic attack (TIA); 4. Structural abnormalities of the left atrial appendage (e.g., LAA thrombus, LAA malformation, LAA diverticulum); 5. Severe cardiac dysfunction (left ventricular ejection fraction 265 µmol/L); 7. Coagulation disorders (prothrombin time > 16 seconds, activated partial thromboplastin time > 45 seconds, platelet count < 100 × 10?/L); 8. Malignant tumor (life expectancy < 1 year); 9. Psychiatric or cognitive impairment, unable to cooperate with follow-up; 10. Allergy to materials used in the left atrial appendage clip (e.g., titanium alloy);

Design outcomes

Primary

MeasureTime frame
postoperative atrial fibrillation, POAF;

Secondary

MeasureTime frame
Length of postoperative hospital stay;1-year cardiovascular readmission rate;Incidence of grade >=3 adverse events within 30 days after surgery and incidence of grade >=4 adverse events during the 2-year follow-up period.;Cerebrovascular accident (CVA);

Countries

China

Contacts

Public ContactZhenghua Xiao

West China Hospital of Sichuan University

xiaozhenghua@wchscu.cn+86 28 8542 1833

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026