Using a chest tube to reduce heart rhythm issues after heart surgery
Prolonged Posterior Pericardial Chest Tube Treatment to Reduce Rates of Postoperative Atrial Fibrillation Following Cardiac Surgery
This study is testing if using a special chest tube after heart surgery can help reduce the chances of patients developing heart rhythm problems like atrial fibrillation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 624 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Region Skane Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Lund) |
| Trial ID | NCT06800781 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of prolonged treatment with a posterior pericardial chest tube in reducing postoperative atrial fibrillation (POAF) rates following cardiac surgery. A total of 624 patients undergoing routine cardiac procedures will be randomly assigned to receive either the chest tube treatment alongside standard care or standard care alone for up to three days post-surgery. The primary goal is to determine the proportion of patients experiencing POAF within seven days after surgery, with a target of achieving a 30% reduction in risk. Secondary outcomes will include measuring the burden of atrial fibrillation and the number of days patients experience this condition.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older undergoing non-emergent cardiac surgeries such as coronary artery bypass grafting or aortic valve replacement.
Not a fit: Patients with a history of atrial fibrillation or those undergoing specific types of aortic surgery involving circulatory arrest may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly lower the incidence of postoperative atrial fibrillation, leading to improved recovery and outcomes for cardiac surgery patients.
How similar studies have performed: Previous studies have indicated that interventions like posterior pericardiotomy can reduce POAF rates, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Lund
- Lund University hospital — Lund, Sweden (Recruiting)
Study contacts
- Principal investigator: Igor Zindovic Zindovic, MD, PhD — Region Skane
- Study coordinator: Igor Zindovic, MD, Phd
- Email: igor.zindovic@skane.se
- Phone: +4646175288
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.