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

Active, not recruiting

• Conditions: Atrial Fibrillation
• Interventions: Other: Non-Interventional

• Registration Number: NCT05903222
• Lead Sponsor: Weill Medical College of Cornell University

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.

Study Timeline

• Study Start: 2022-07-01
• Study First Submitted: 2023-06-05
• Study First Submitted QC: 2023-06-05
• Study First Posted: 2023-06-15
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-21
• Last Update Posted: 2024-05-22
• Primary Completion: 2024-10-15
• Study Completion: 2024-10-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 420

Inclusion Criteria

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

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Exclusion Criteria

• Not enrolled in the PALACS trial

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Posterior Pericardiotomy	Non-Interventional	All patients who were randomized to receive posterior pericardiotomy (intervention) in the original PALACS trial.

Primary Outcome Measures

Name	Time	Method
Time to first occurrence of the composite of all-cause mortality and hospital readmission for cardiovascular causes	Median five-year follow-up

Secondary Outcome Measures

Name	Time	Method
Number of Adverse Events	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
Time to first occurrence of the composite of all-cause mortality and all-cause hospital readmission	Median five-year follow-up

Trial Locations

Locations (1)

Weill Cornell Medical College Department of Cardiothoracic Surgery; 🇺🇸 New York, New York, United States