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Prolonged Chest Tube Treatment to Reduce Rates of Atrial Fibrillation Following Cardiac Surgery

RecruitingNAAges 18 Years - anyAllRegion Skane
NCT06800781 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Evacuation of pericardial blood by posterior pericardiotomy or use of a posterior pericardial chest tube lowers postoperative atrial fibrillation (POAF) rates after cardiac surgery by 45-68%. Although it cannot be generalized due to trial undersizing, posterior pericardial chest tube treatment may be a superior alternative to pericardiotomy, given its low risk of procedural complications. This interventional multicenter trial will assess whether prolonged treatment with a posterior pericardial chest tube lowers POAF rates after cardiac surgery. Investigators will randomize 624 patients undergoing routine cardiac surgery at Nordic sites 1:1 to receive a posterior pericardial chest tube as adjunct to standard care for up to 3 postoperative days or standard care alone. The primary outcome is the proportion of patients with POAF up to 7 days post-surgery; the study will be powered to detect

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥ 18 years * Undergoing non-emergent surgery (\>24 hours between decision to operate and surgical procedure) with coronary artery bypass grafting, aortic valve replacement, aortic surgery without the use of circulatory arrest, or any combination of these procedures * Able to give written informed consent Exclusion Criteria: * History of atrial fibrillation (AF) or atrial flutter * History of electrophysiological interventions or treatment with antiarrhythmic drugs due to arrhythmias other than AF * Pre- or postoperative prophylactic treatment with amiodarone * Existing pacemaker, ICD, or CRT device without a functional atrial lead * Aortic surgery with hypothermic circulatory arrest * Previous cardiac surgery * Previous radiation of the chest due to malignancy * Ongoing infection at time of surgery * Ongoing treatment with immunosuppressants, including oral corticosteroids * Patient already included in another interventional clinical trial * Patient listed abroad, which would render them to be lost to follow-up after discharge * Patient does not understand study information given in the local language or, for other reasons, is deemed unfit to participate according to the investigators.
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What it tests

  • Prolonged treatment with posterior pericardial chest tube plus standard care
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Where

1 site
Lund University hospital
Lund, Sweden
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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