NCT06800781 Prolonged Chest Tube Treatment to Reduce Rates of Atrial Fibrillation Following Cardiac Surgery
| NCT ID | NCT06800781 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Region Skane |
| Condition | Coronary Arterial Disease (CAD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 624 participants |
| Start Date | 2025-02-10 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 624 participants in total. It began in 2025-02-10 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Igor Zindovic Zindovic, MD, PhD
PRINCIPAL INVESTIGATOR
Region Skane
Frequently Asked Questions
Who can join the NCT06800781 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Arterial Disease (CAD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06800781 currently recruiting?
Yes, NCT06800781 is actively recruiting participants. Contact the research team at igor.zindovic@skane.se for enrollment information.
Where is the NCT06800781 trial being conducted?
This trial is being conducted at Lund, Sweden.
Who is sponsoring the NCT06800781 clinical trial?
NCT06800781 is sponsored by Region Skane. The principal investigator is Igor Zindovic Zindovic, MD, PhD at Region Skane. The trial plans to enroll 624 participants.