Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06800781

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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