ClinConnect ClinConnect Logo
Search / Trial NCT06800781

Prolonged Chest Tube Treatment to Reduce Rates of Atrial Fibrillation Following Cardiac Surgery

Launched by REGION SKANE · Jan 23, 2025

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Posterior Pericardial Chest Tube Postoperative Atrial Fibrillation (Poaf)

ClinConnect Summary

This clinical trial is studying whether using a special chest tube for a longer period after heart surgery can help reduce the chances of patients developing an irregular heartbeat, known as postoperative atrial fibrillation (POAF). The researchers will involve 624 patients who are having routine heart surgeries, such as coronary artery bypass grafting or valve replacements. Participants will be randomly assigned to either receive the chest tube along with standard care for up to three days after surgery or just standard care alone. The main goal is to see if the chest tube can lower the rates of POAF within the first week after surgery.

To be eligible for this study, patients must be at least 18 years old and scheduled for non-emergency heart surgery. They should not have a history of irregular heartbeats or other specific heart conditions that might interfere with the trial. If someone joins the study, they can expect close monitoring during their hospital stay, and the researchers will track various health outcomes for up to five years. This trial aims to provide valuable information that could lead to better care after heart surgery and potentially lower healthcare costs.

Gender

ALL

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.

About Region Skane

Region Skåne is a leading healthcare authority in Sweden, dedicated to advancing medical research and improving patient care through innovative clinical trials. Committed to fostering collaboration between researchers, healthcare professionals, and patients, Region Skåne aims to enhance the understanding of various health conditions and develop effective treatment strategies. With a focus on ethical standards and patient safety, the organization plays a pivotal role in shaping the future of healthcare in the region and beyond, ensuring that clinical trials are conducted with the highest level of scientific rigor and transparency.

Locations

Lund, , Sweden

Patients applied

0 patients applied

Trial Officials

Igor Zindovic Zindovic, MD, PhD

Principal Investigator

Region Skåne

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported