Impact of Ligament of Marshall Resection on Atrial Fibrillation Occurrence in Patients Undergoing… (NCT07492901) | Clinical Trial Compass
CompletedNot Applicable
Impact of Ligament of Marshall Resection on Atrial Fibrillation Occurrence in Patients Undergoing Coronary Artery Bypass Grafting: A Randomized Controlled Trial
Egypt220 participantsStarted 2024-01-11
Plain-language summary
Background: 20-40% of patients with ischemic heart disease managed with coronary artery bypass grafting (CABG) surgeries face the risk of postoperative atrial fibrillation (POAF), which is a known hazardous outcome. Being a well-known arrhythmogenic pathway, surgical excision of the ligament of Marshall may, theoretically, lower the incidence of POAF. Aim: In this study, we aimed to assess the safety and efficacy of prophylactic LoM resection in preventing POAF after on-pump CABG (ON-CAB.). Methods: 220 patients at elevated risk for POAF undergoing elective ON-CAB were randomized to receive either standard CABG alone (n = 110) or adjunctive LoM resection (n = 110) in this multicenter, randomized, assessor- and patient-blinded study with unblinded surgeons. ECG-verified POAF occurring within seven days was the primary outcome. Mortality, use of resources, and pharmaceutical therapy were secondary outcomes.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Adults aged ≥18 years.
Scheduled for elective on-pump coronary artery bypass grafting (CABG).
Diagnosed with multivessel coronary artery disease or left main disease requiring surgical revascularization according to current guidelines.
Classified as high risk for postoperative atrial fibrillation, defined as the presence of at least two of the following:
Age ≥65 years
Left atrial enlargement (anteroposterior diameter \>40 mm on transthoracic echocardiography)
History of paroxysmal atrial fibrillation not requiring long-term anticoagulation
Chronic obstructive pulmonary disease requiring regular pharmacological therapy
Ability to provide written informed consent.
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Exclusion Criteria:
Preoperative atrial fibrillation requiring active treatment or long-term anticoagulation.
History of previous cardiac surgery.
Severe left ventricular systolic dysfunction (ejection fraction \<30%).
Emergency or urgent CABG.
Concomitant cardiac procedures (e.g., valve surgery, surgical ablation for atrial fibrillation).
Contraindications to anticoagulation or antiarrhythmic therapy.
Inability or unwillingness to provide informed consent.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of postoperative atrial fibrillation (POAF)
Timeframe: Within 7 days after coronary artery bypass grafting