The Effect of Posterior Pericardiotomy on the Incidence of Atrial Fibrillation After Cardiac Surgery-Extended Follow-Up
NCT ID: NCT05903222
Last Updated: 2025-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
420 participants
OBSERVATIONAL
2022-07-01
2024-10-13
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Posterior Pericardiotomy
All patients who were randomized to receive posterior pericardiotomy (intervention) in the original PALACS trial.
Non-Interventional
This study is a non-interventional study of all patients previously enrolled in the PALACS trial
No Posterior Pericardiotomy (control)
All patients who were randomized to receive no intervention/no posterior pericardiotomy in the original PALACS trial
No interventions assigned to this group
Interventions
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Non-Interventional
This study is a non-interventional study of all patients previously enrolled in the PALACS trial
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Weill Medical College of Cornell University
OTHER
Responsible Party
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Principal Investigators
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Leonard N Girardi, MD
Role: PRINCIPAL_INVESTIGATOR
Weill Cornell Medical College New York Presbyterian Hospital
Mario Gaudino, MD
Role: STUDY_CHAIR
Weill Cornell Medical College New York Presbyterian Hospital
Locations
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Weill Cornell Medical College Department of Cardiothoracic Surgery
New York, New York, United States
Countries
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References
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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.
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.
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.
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.
Related Links
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Weill Cornell Department of Cardiothoracic Surgery
Other Identifiers
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1502015867-Extension
Identifier Type: -
Identifier Source: org_study_id
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