Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06800781

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

Led by Region Skane · Updated on 2026-04-29

624

Participants Needed

1

Research Sites

313 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

Postoperative atrial fibrillation (POAF) happens in 20-50% of patients after cardiac surgery and is linked to worse outcomes like stroke, longer hospital stays, and higher death rates. This trial is studying whether using a posterior pericardial chest tube for a longer time after surgery can reduce the rate of POAF. The study compares this method to standard care and aims to provide strong evidence to support its use in routine cardiac surgery.

CONDITIONS

Brief 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-emergent coronary artery bypass grafting, aortic valve replacement, aortic surgery without circulatory arrest, or any combination of these procedures
  • Able to provide written informed consent
Not Eligible

You will not qualify if you...

  • History of atrial fibrillation or atrial flutter
  • History of electrophysiological interventions or use of antiarrhythmic drugs for arrhythmias other than atrial fibrillation
  • 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 chest radiation due to malignancy
  • Ongoing infection at time of surgery
  • Ongoing treatment with immunosuppressants, including oral corticosteroids
  • Currently enrolled in another interventional clinical trial
  • Listed abroad and likely to be lost to follow-up after discharge
  • Unable to understand study information in the local language or deemed unfit to participate by investigators

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Up to 3 days post-surgery

Participants undergo cardiac surgery and receive chest tubes as part of standard care. Those in the intervention group receive an additional posterior pericardial chest tube, which remains in place for drainage until postoperative Day 3 or until chest tube output is less than 50 mL per 24 hours.

Daily visits while hospitalized (in-person)

Post-operative Follow-up

Duration - Up to 30 days post-surgery

Participants are monitored for postoperative atrial fibrillation (POAF) using the SmartCardia heart rate monitor for up to 14 days after surgery. Clinical assessments continue during the hospital stay and until postoperative day 30 to evaluate recovery and complications.

Continuous heart rhythm monitoring for 14 days and regular clinical visits until day 30 (in-person and remote monitoring)

Long-term Monitoring

Duration - Up to 5 years post-discharge

Participants are followed for up to 5 years after hospital discharge to monitor for atrial fibrillation recurrence, stroke, bleeding events, survival, quality of life, and healthcare outcomes.

Periodic follow-up visits and assessments over 5 years (in-person or remote)

Trial Site Locations

Total: 1 location

1

Lund University hospital

Lund, Sweden

Actively Recruiting

Loading map...

Research Team

I

Igor Zindovic, MD, Phd

D

David Mörtsell, MD, Phd

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

Similar Trials

A Single Centre Study Comparing Continuous Interstitial Flui...

Coronary Artery Bypass

Actively Recruiting

1 location

AGENT DCB STANCE: AGENT Drug-Coated Balloon for STent AvoidA...

Coronary Arterial Disease (CAD)

Actively Recruiting

55 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Gender Differences in Predictors and Long-Term Mortality of New-Onset Postoperative Atrial Fibrillation Following Isolated Aortic Valve Replacement Surgery.

Mariana Fragão-Marques, Jennifer Mancio, João Oliveira...

https://pubmed.ncbi.nlm.nih.gov/32350163

Effect of posterior pericardial drainage on the incidence of pericardial effusion after ascending aortic surgery.

Sadik Eryilmaz, Ozan Emiroglu, Zeynep Eyileten...

https://pubmed.ncbi.nlm.nih.gov/16798298

A randomized prospective multicenter trial for stroke prevention by prophylactic surgical closure of the left atrial appendage in patients undergoing bioprosthetic aortic valve surgery--LAA-CLOSURE trial protocol.

Tuomas Kiviniemi, Juan Bustamante-Munguira, Christian Olsson...

https://pubmed.ncbi.nlm.nih.gov/33798494

Posterior pericardiotomy to prevent new-onset atrial fibrillation after coronary artery bypass grafting: a systematic review and meta-analysis of 10 randomized controlled trials.

Tao Xiong, Lei Pu, Yuan-Feng Ma...

https://pubmed.ncbi.nlm.nih.gov/34391454

Systematic review and meta-analysis of randomized controlled trials assessing safety and efficacy of posterior pericardial drainage in patients undergoing heart surgery.

Mirosław Gozdek, Wojciech Pawliszak, Wojciech Hagner...

https://pubmed.ncbi.nlm.nih.gov/28087110

Posterior left pericardiotomy for the prevention of atrial fibrillation after cardiac surgery: an adaptive, single-centre, single-blind, randomised, controlled trial.

Mario Gaudino, Tommaso Sanna, Karla V Ballman...

https://pubmed.ncbi.nlm.nih.gov/34788640