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Completed

NCT Number: NCT05903222

The Effect of Posterior Pericardiotomy on the Incidence of Atrial Fibrillation After Cardiac Surgery-Extended Follow-Up

The purpose of the Effect of Posterior Pericardiotomy on the Incidence of Atrial Fibrillation After Cardiac Surgery (PALACS, NCT02875405) trial was to determine if performing posterior left pericardiotomy at the time of cardiac surgery prevents atrial fibrillation after cardiac surgery. The purpose of the Posterior left pericardiotomy for the prevention of AtriaL fibrillation After Cardiac Surgery-Extended Follow-Up (PALACS-EF) study is to evaluate the effect of posterior left pericardiotomy on 5-year clinical outcomes.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Weill Cornell Medical College Department of Cardiothoracic Surgery

New York, 10065, United States

About this study

Post-operative atrial fibrillation (POAF) is a common complication of cardiac surgery which is observed in 30-40% of patients. POAF has also been associated with stroke, systemic embolism or cardiac failure during the years after surgery. Several strategies aimed at reducing the incidence of POAF have been investigated, including beta-blockers, amiodarone, and statins, with unsatisfactory results. In the randomized prospective clinical trial, the PALACS trial, 420 patients were randomized either to the intervention group, which received left posterior pericardiotomy at time of cardiac surgery, or to the control group, which did not receive posterior left pericardiotomy at time of cardiac surgery. Posterior left pericardiotomy was associated with a reduction in the incidence of POAF after surgery, but not with improvement in 30-day patient outcomes.

This non-interventional, prospective study is an extension follow-up study (PALACS-EF) of all patients who were enrolled in the original PALACS trial. It is designed to evaluate differences in clinical outcomes between patients who received posterior left pericardiotomy (intervention) versus those who did not (control) at median follow-up of 5 years.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • This study will include all the subjects enrolled in the PALACS trial

Exclusion criteria

  • Not enrolled in the PALACS trial

Treatment and study plan

Non-Interventional

Other

This study is a non-interventional study of all patients previously enrolled in the PALACS trial

Primary outcomes

  1. Time to first occurrence of the composite of all-cause mortality and hospital readmission for cardiovascular causes

    Time frame: Median five-year follow-up

Secondary outcomes

  1. Time to first occurrence of the composite of all-cause mortality and all-cause hospital readmission

    Time frame: Median five-year follow-up

  2. Number of Adverse Events

    Time frame: Median five-year follow-up

    The following adverse events will be included in the count: Myocardial infarction, stroke, transient ischemic attack, new arrhythmia (atrial fibrillation versus non-atrial fibrillation), heart failure, systemic embolism

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Official study title

The Effect of Posterior Pericardiotomy on the Incidence of Atrial Fibrillation After Cardiac Surgery - Extended Follow-Up (PALACS-EF) Study

Acronym: PALACS-EF

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 15, 2023
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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