Prolonged Chest Tube Treatment to Reduce Rates of Atrial Fibrillation Following Cardiac Surgery (NCT06800781) | Clinical Trial Compass
RecruitingNot Applicable
Prolonged Chest Tube Treatment to Reduce Rates of Atrial Fibrillation Following Cardiac Surgery
Sweden624 participantsStarted 2025-02-10
Plain-language summary
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 a relative risk reduction of 30% in the intervention arm. Secondary outcomes are AF burden; days with chest tubes and their output; proportion of patients with POAF up to 14 days post-surgery; direct current conversions during hospital admission; length of ICU/hospital stay; postoperative complications, mortality, ischemic stroke, and major bleeding at 30/90 days and 1/3/5 years; and quality of life/postoperative recovery at 90 days and 1 year. This trial may provide quality clinical evidence supporting the adoption of a simple method to prevent POAF, thus reducing healthcare costs.
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:
* 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.
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.
1This trial is looking at whether leaving chest tubes in longer after cardiac surgery can reduce the risk of atrial fibrillation in the first week — how does that approach compare to what you'd normally do after my type of surgery, whether that's coronary bypass, valve replacement, or aortic surgery?
2Since this trial is listed as Phase NA, meaning it may not follow the typical Phase 1–3 safety progression, what is already known about the risks of keeping chest tubes in for a longer period, and what does that mean for my safety if I were to take part?
3What exactly would be different about my post-operative care if I joined this study versus standard care — would I have tubes in for a longer time, and how might that affect my pain, mobility, or length of hospital stay?
4If atrial fibrillation after cardiac surgery is already a known risk, are there existing standard treatments or preventive medications that my care team would use regardless, and how would joining this trial fit alongside or instead of those approaches?
5Given that this trial is still actively recruiting and results aren't yet available, how would you weigh the potential benefit of participating against choosing a well-established post-operative care plan for my specific condition?
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
Proportion of patients with POAF the first 7 postoperative days
Timeframe: From enrollment (randomization) to postoperative day 7