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

NCT05903222 | Completed

• 1 other identifier: 1502015867-Extension
• Study Type: observational
• Target: 420
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

postoperative; left posterior pericardiotomy; prevention; cardiac surgery

Outcome Measures

Primary Outcomes (1)

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

  Median five-year follow-up

Secondary Outcomes (2)

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

  Median five-year follow-up

• Number of Adverse Events

  Median five-year follow-up

Study Arms (2)

Posterior Pericardiotomy

All patients who were randomized to receive posterior pericardiotomy (intervention) in the original PALACS trial.

Other: Non-Interventional

No Posterior Pericardiotomy (control)

All patients who were randomized to receive no intervention/no posterior pericardiotomy in the original PALACS trial

Interventions

Non-Interventional OTHER

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

Posterior Pericardiotomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients enrolled in the PALACS trial

You may qualify if:

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

You may not qualify if:

• Not enrolled in the PALACS trial

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medical College Department of Cardiothoracic Surgery

New York, New York, 10065, United States

Location

Related Publications (4)

• Biancari F, Mahar MA. Meta-analysis of randomized trials on the efficacy of posterior pericardiotomy in preventing atrial fibrillation after coronary artery bypass surgery. J Thorac Cardiovasc Surg. 2010 May;139(5):1158-61. doi: 10.1016/j.jtcvs.2009.07.012. Epub 2009 Aug 18.

  PMID: 19691996 BACKGROUND

• Kaleda VI, McCormack DJ, Shipolini AR. Does posterior pericardiotomy reduce the incidence of atrial fibrillation after coronary artery bypass grafting surgery? Interact Cardiovasc Thorac Surg. 2012 Apr;14(4):384-9. doi: 10.1093/icvts/ivr099. Epub 2012 Jan 9.

  PMID: 22235005 BACKGROUND

• Gaudino M, Sanna T, Ballman KV, Robinson NB, Hameed I, Audisio K, Rahouma M, Di Franco A, Soletti GJ, Lau C, Rong LQ, Massetti M, Gillinov M, Ad N, Voisine P, DiMaio JM, Chikwe J, Fremes SE, Crea F, Puskas JD, Girardi L; PALACS Investigators. Posterior left pericardiotomy for the prevention of atrial fibrillation after cardiac surgery: an adaptive, single-centre, single-blind, randomised, controlled trial. Lancet. 2021 Dec 4;398(10316):2075-2083. doi: 10.1016/S0140-6736(21)02490-9. Epub 2021 Nov 14.

  PMID: 34788640 BACKGROUND

• Gaudino M, Harik L, Redfors B, Sandner S, Alexander JH, Di Franco A, Dimagli A, Weinsaft J, Perezgrovas-Olaria R, Soletti GJ, Lau C, Mack C, Girardi L. The Effect of Posterior Pericardiotomy on the Incidence of Atrial Fibrillation After Cardiac Surgery-Extended Follow-Up study (PALACS-EF): rationale and design. Eur Heart J Open. 2023 Nov 17;3(6):oead118. doi: 10.1093/ehjopen/oead118. eCollection 2023 Nov.

  PMID: 38035038 DERIVED

Related Links

• Weill Cornell Department of Cardiothoracic Surgery

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Leonard N Girardi, MD

  Weill Cornell Medical College New York Presbyterian Hospital

  PRINCIPAL INVESTIGATOR

• Mario Gaudino, MD

  Weill Cornell Medical College New York Presbyterian Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: June 15, 2023
• Study Start: July 1, 2022
• Primary Completion: September 26, 2024
• Study Completion: October 13, 2024
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)