What is this study testing for patients undergoing cardiac surgery?

This study is evaluating whether prolonged use of a posterior pericardial chest tube after cardiac surgery lowers the chances of developing postoperative atrial fibrillation (POAF). Researchers aim to find out if this method can reduce this common complication and improve patient recovery after surgery.

Who may be eligible for this cardiac surgery clinical trial?

Adults 18 years or older undergoing non-emergent coronary artery bypass grafting, aortic valve replacement, or aortic surgery without circulatory arrest may be eligible. People with a history of atrial fibrillation, previous cardiac surgery, or who are on immunosuppressants are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this cardiac surgery clinical trial?

Study-related care, including the chest tube treatment and all trial visits, is provided at no cost. However, personal travel and other expenses may vary and are not guaranteed to be covered by the study.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID06800781

Evaluating Extended Posterior Pericardial Chest Tube Use to Lower Atrial Fibrillation After Cardiac Surgery

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

624

Participants Needed

Research Sites

313 weeks

Total Duration

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

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

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

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)

Research Team

Igor Zindovic, MD, Phd

David Mörtsell, MD, Phd

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

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Frequently Asked Questions

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

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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/

RR interval dynamics before atrial fibrillation in patients after coronary artery bypass graft surgery.

C W Hogue, P P Domitrovich, P K Stein...

https://pubmed.ncbi.nlm.nih.gov/9714093/

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/

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/

Cardiopulmonary bypass induced inflammation: pathophysiology and treatment. An update.

D Paparella, T M Yau, E Young

https://pubmed.ncbi.nlm.nih.gov/11825729/

Pericardial Blood as a Trigger for Postoperative Atrial Fibrillation After Cardiac Surgery.

Samuel St-Onge, Louis P Perrault, Philippe Demers...

https://pubmed.ncbi.nlm.nih.gov/29174782/

New-Onset Atrial Fibrillation After Coronary Artery Bypass Grafting and Long-Term Outcome: A Population-Based Nationwide Study From the SWEDEHEART Registry.

Amar Taha, Susanne J Nielsen, Lennart Bergfeldt...

https://pubmed.ncbi.nlm.nih.gov/33251914/

Rate Control versus Rhythm Control for Atrial Fibrillation after Cardiac Surgery.

A Marc Gillinov, Emilia Bagiella, Alan J Moskowitz...

https://pubmed.ncbi.nlm.nih.gov/27043047/

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/

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/

Evaluating Extended Posterior Pericardial Chest Tube Use to Lower Atrial Fibrillation After Cardiac Surgery

On this page

Sponsors

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Your Study Journey

Research Team

How is the study designed?

Similar Trials

Study Comparing AGENT Drug-Coated Balloon to Standard PCI Tr...

Study on the Effects of Spirulina and Gelidium Algae Supplem...

Study of AI-Based ECG Analysis to Detect Acute Coronary Occl...

Frequently Asked Questions

What is this study testing for patients undergoing cardiac surgery?

Who may be eligible for this cardiac surgery clinical trial?

Is there any cost to participate in this cardiac surgery clinical trial?

Will I receive the posterior pericardial chest tube or standard care?

How will atrial fibrillation be monitored during the study?

What happens after this cardiac surgery clinical trial ends?

Can I leave this cardiac surgery clinical trial if I change my mind?

Not the Right Trial for You?

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.

RR interval dynamics before atrial fibrillation in patients after coronary artery bypass graft surgery.

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

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

Cardiopulmonary bypass induced inflammation: pathophysiology and treatment. An update.

Pericardial Blood as a Trigger for Postoperative Atrial Fibrillation After Cardiac Surgery.

New-Onset Atrial Fibrillation After Coronary Artery Bypass Grafting and Long-Term Outcome: A Population-Based Nationwide Study From the SWEDEHEART Registry.

Rate Control versus Rhythm Control for Atrial Fibrillation after Cardiac Surgery.

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

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

On this page

Sponsors

Sponsors

Who Can Participate

Eligibility Criteria

Your Study Journey

How is the study designed?

Similar Trials

Study Comparing AGENT Drug-Coated Balloon to Standard PCI Tr...

Study on the Effects of Spirulina and Gelidium Algae Supplem...

Study of AI-Based ECG Analysis to Detect Acute Coronary Occl...

Frequently Asked Questions

What is this study testing for patients undergoing cardiac surgery?

Who may be eligible for this cardiac surgery clinical trial?

Is there any cost to participate in this cardiac surgery clinical trial?

Will I receive the posterior pericardial chest tube or standard care?

How will atrial fibrillation be monitored during the study?

What happens after this cardiac surgery clinical trial ends?

Can I leave this cardiac surgery clinical trial if I change my mind?

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.

RR interval dynamics before atrial fibrillation in patients after coronary artery bypass graft surgery.

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

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

Cardiopulmonary bypass induced inflammation: pathophysiology and treatment. An update.

Pericardial Blood as a Trigger for Postoperative Atrial Fibrillation After Cardiac Surgery.

New-Onset Atrial Fibrillation After Coronary Artery Bypass Grafting and Long-Term Outcome: A Population-Based Nationwide Study From the SWEDEHEART Registry.

Rate Control versus Rhythm Control for Atrial Fibrillation after Cardiac Surgery.

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

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

Sponsors