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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05903222
Acronym
PALACS-EF
Enrollment
420
Registered
2023-06-15
Start date
2022-07-01
Completion date
2024-10-13
Last updated
2025-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

postoperative, left posterior pericardiotomy, prevention, cardiac surgery

Brief summary

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.

Detailed description

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.

Interventions

OTHERNon-Interventional

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

Sponsors

Weill Medical College of Cornell University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Not enrolled in the PALACS trial

Design outcomes

Primary

MeasureTime frame
Time to first occurrence of the composite of all-cause mortality and hospital readmission for cardiovascular causesMedian five-year follow-up

Secondary

MeasureTime frameDescription
Time to first occurrence of the composite of all-cause mortality and all-cause hospital readmissionMedian five-year follow-up
Number of Adverse EventsMedian five-year follow-upThe 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026