NCT06800781Recruiting
Prolonged Chest Tube Treatment to Reduce Rates of Atrial Fibrillation Following Cardiac Surgery
Prolonged Posterior Pericardial Chest Tube Treatment to Reduce Rates of Postoperative Atrial Fibrillation Following Cardiac Surgery
Source: ClinicalTrials.gov · Last updated 29 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 624 (estimated)
- First submitted
- 8 Jan 2025
- Start date
- 10 Feb 2025
- Primary completion date
- Dec 2027
- Lead sponsor
- Region Skane
- Diseases
- Atrial fibrillation
- NCT number
- NCT06800781
What you commit to
- Study type: Interventional
- Planned participants: 624
- From 10 Feb 2025 to the primary completion date, Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of electrophysiological interventions or treatment with antiarrhythmic drugs due to arrhythmias other than AF
- Pre- or postoperative prophylactic treatment with amiodarone
- Aortic surgery with hypothermic circulatory arrest
- Previous cardiac surgery
- Previous radiation of the chest due to malignancy
- Ongoing treatment with immunosuppressants, including oral corticosteroids
Other illness
- History of atrial fibrillation (AF) or atrial flutter
- Ongoing infection at time of surgery
Other
- Existing pacemaker, ICD, or CRT device without a functional atrial lead
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Lund University Hospital Coordinator of this site? Confirm its status | Lund | Sweden | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.