Actively Recruiting
Prolonged Chest Tube Treatment to Reduce Rates of Atrial Fibrillation Following Cardiac Surgery
Led by Region Skane · Updated on 2026-04-29
624
Participants Needed
1
Research Sites
459 weeks
Total Duration
On this page
Sponsors
R
Region Skane
Lead Sponsor
T
The Swedish Research Council
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prolonged Chest Tube Treatment to Reduce Rates of Atrial Fibrillation Following Cardiac Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Undergoing non-emergency cardiac surgery including coronary artery bypass grafting, aortic valve replacement, or aortic surgery without circulatory arrest
- Able to provide written informed consent
You will not qualify if you...
- History of atrial fibrillation or atrial flutter
- History of electrophysiological treatment or use of antiarrhythmic drugs for arrhythmias other than atrial fibrillation
- Pre- or postoperative preventive treatment with amiodarone
- Presence of pacemaker, ICD, or CRT device without a functional atrial lead
- Aortic surgery involving hypothermic circulatory arrest
- Previous cardiac surgery
- Previous chest radiation for cancer
- Active infection at time of surgery
- Current treatment with immunosuppressants, including oral corticosteroids
- Participation in another interventional clinical trial
- Patient listed abroad making follow-up unlikely
- Inability to understand study information in local language or deemed unfit by investigators
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Trial Site Locations
Total: 1 location
1
Lund University hospital
Lund, Sweden
Actively Recruiting
Research Team
I
Igor Zindovic, MD, Phd
CONTACT
D
David Mörtsell, MD, Phd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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