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临床试验/NCT07755072
NCT07755072尚未招募不适用

The Effect of Ligament of Marshall Excision During Minimally Invasive Cardiac Surgery-Coronary Artery Bypass Grafting (MICS-CABG) on the Prevention of Postoperative New-Onset Atrial Fibrillation: A Multicenter, Prospective, Randomized, Triple-Blinded Study

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 628 人开始时间: 2026年7月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
628
试验地点
1
主要终点
Primary Endpoints

研究概览

简要总结

After heart bypass surgery, many patients develop a heart rhythm problem called postoperative atrial fibrillation, or POAF for short. This issue happens to 20%-40% of all bypass patients. Even with smaller, less invasive surgical cuts or robot-assisted heart bypass operations, between 4.8% and 18.4% of people still get POAF.

When POAF occurs, patients usually stay in the hospital longer and face higher medical bills. It also raises chances of serious complications like stroke, heart failure and heart attacks, and lowers long-term survival rates. Stopping POAF early is therefore key to helping patients recover better after surgery.

POAF comes from two main causes: personal health risks and stress from the surgery itself. Older age, high blood pressure, heart failure, lung disease, diabetes and overweight all make people more likely to develop irregular heart rhythms after an operation. Surgical trauma also plays a big role: cutting the breastbone, fluid building up around the heart, inflammation from heart-lung machines, pulling or stitching heart tissue, and unbalanced nerve signals during recovery can all spark POAF. Earlier studies have shown simple surgical adjustments can lower POAF risk safely, giving us a good basis to improve current surgery methods.

The Ligament of Marshall is a fibrous bundle-like structure left over from heart development before birth. Its special tissue structure makes it easy to trigger chaotic heart beats. It holds muscle tissue that creates looping abnormal electrical signals, plus nerve clusters that overactivate the body's stress response after surgery - this is a major cause of POAF. Doctors who fix irregular heart rhythms with catheter burns already target this ligament to stop repeat atrial fibrillation. Major heart surgery for long-term irregular heartbeats also routinely cuts this ligament without adding extra surgical risks.

Our study will collect real clinical data to deepen the understanding of POAF and partial denervation therapy. Cutting the Ligament of Marshall during minimally invasive cardiac surgery-coronary artery bypass grafting (MICS-CABG) is an easy, low-risk step with no extra risk of collateral injury. We hope this method can lower the chance of irregular heartbeats after surgery, reduce the need for rhythm-control drugs and their side effects, and help patients maintain stable heart function and better daily life right after surgery.

For MICS-CABG, doctors do not need extra complicated steps to see and cut the Ligament of Marshall. We only make a small cut between the ribs on the left chest. After pericardial incision and suspension, this fibrous bundle-like structure is clearly visible and simple to operate on. Compared with traditional open-heart surgery that splits the whole breastbone, this small-cut approach avoids rough handling of the left heart and lessens overall surgical stress on patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 18-80 years;
  • Coronary artery lesions meeting the indications for surgical revascularization, with planned MICS-CABG;
  • Signed an informed consent form agreeing to participate in the study;

排除标准

  • Patients with preoperative hemodynamic instability requiring emergency surgery;
  • History of paroxysmal or persistent atrial fibrillation prior to surgery;
  • Echocardiographic left atrial anteroposterior diameter (APD) ≥ 60 mm;
  • Patients with ejection fraction (EF) < 40%, left ventricular diastolic dimension (LVDD) > 60 mm, left ventricular aneurysm, or severe arrhythmia who are at high risk of intraoperative hemodynamic instability;
  • Patients with concomitant mitral stenosis or regurgitation of moderate severity or greater;
  • Patients undergoing concurrent valve surgery or other intracardiac corrective procedures;
  • Patients with a history of renal insufficiency;
  • Patients receiving intra-aortic balloon pump (IABP) or extracorporeal membrane oxygenation (ECMO) circulatory support preoperatively;
  • Patients taking antiarrhythmic drugs other than beta-blockers prior to surgery, such as propafenone or amiodarone;
  • History of cardiac or thoracic surgery;
  • Poor pulmonary function, with a preoperative arterial blood gas analysis oxygen partial pressure (PaO₂) < 60 mmHg at rest without oxygen supplementation;
  • Patients with a preoperative pacemaker implant;

研究组 & 干预措施

MICS-CABG combined with excision of the Ligament of Marshall

Experimental

干预措施: MICS-CABG combined with excision of the Ligament of Marshall (Procedure)

MICS-CABG without excision of the Ligament of Marshall

No Intervention

结局指标

主要结局

Primary Endpoints

时间窗: During the postoperative hospital stay

Each episode of POAF lasting ≥30 seconds during the postoperative hospital stay.

次要结局

  • Secondary Endpoints(Postoperative month 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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