The Effect of Posterior Pericardiotomy on the Incidence of Atrial Fibrillation After Cardiac Surgery (PALACS)
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Posterior left pericardiotomy
Sponsored by
About this trial
This is an interventional prevention trial for Atrial Fibrillation focused on measuring postoperative, pericardiotomy, prevention, cardiac surgery, left, posterior
Eligibility Criteria
Inclusion Criteria:
- all consecutive patients admitted to the department of cardiothoracic surgery of the NYPH-WCMC will be screened for enrollment.
Exclusion Criteria:
- preoperative non-sinus rhythm
- history of previous atrial arrhythmia of any type
- reoperations
- mitral or tricuspid valve disease
- surgery of the descending thoracic or thoracoabdominal aorta
- need for hypothermic circulatory arrest
- off pump operation
- urgent/emergent presentation
- disease of the left pleura or previous left thoracotomy
- chest deformity
Sites / Locations
- Weil Cornell Medical College Department of Cardiothoracic Surgery
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Received pericardiotomy
No Pericardiotomy
Arm Description
Patient will receive a posterior left pericardiotomy at the time of surgery
Patient will not receive posterior left pericardiotomy.
Outcomes
Primary Outcome Measures
Number of participants that experience Postoperative Atrial Fibrillation (POAF)
POAF occurrences are defined as any irregular heart rhythm, without detectable P-wave, that lasts more than 30 seconds.
Secondary Outcome Measures
Duration of Postoperative Atrial Fibrillation (POAF)
Time spent in atrial fibrillation (seconds), defined as the time from the first evidence of atrial fibrillation to the first evidence of sinus rhythm restoration on cardiac monitoring strips or standard electrocardiograms (EKG)
Duration of Hospitalization
Time (hours) spent in hospital after surgery completion
Full Information
NCT ID
NCT02875405
First Posted
July 25, 2016
Last Updated
August 26, 2021
Sponsor
Weill Medical College of Cornell University
Collaborators
Catholic University of the Sacred Heart
1. Study Identification
Unique Protocol Identification Number
NCT02875405
Brief Title
The Effect of Posterior Pericardiotomy on the Incidence of Atrial Fibrillation After Cardiac Surgery
Acronym
PALACS
Official Title
The Effect of Posterior Pericardiotomy on the Incidence of Atrial Fibrillation After Cardiac Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
September 20, 2017 (Actual)
Primary Completion Date
August 10, 2021 (Actual)
Study Completion Date
August 24, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
Catholic University of the Sacred Heart
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine if preforming a posterior left pericardiotomy prevents atrial fibrillation after cardiac surgery.
Detailed Description
Post-operative atrial fibrillation (POAF) is a common complication of cardiac surgery which is observed in 30-40% of patients. POAF may cause stroke, systemic embolism or cardiac failure and Its detection mandates for additional treatment with variable combinations of drugs to control cardiac rate or rhythm, anticoagulation, and electrical cardioversion, with their side effects and complications. As a result, POAF prolongs hospital stay and increases the costs of hospitalization. Several strategies aimed at reducing the incidence of POAF have been investigated, including beta-blockers, amiodarone, and statins, with unsatisfactory results. Posterior left pericardiotomy has been associated with a reduction in the incidence of POAF in a few studies. However, these studies are flawed by methodological limitations in terms of sample size, inclusion/exclusion criteria, randomization procedure, and suboptimal electrocardiographic monitoring strategies. Moreover, posterior left pericardiotomy requires additional operative time and is associated with procedure-specific complications. As a result, current evidence on posterior pericardiectomy failed to translate into changes in clinical practice and the incidence of POAF remains high.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
postoperative, pericardiotomy, prevention, cardiac surgery, left, posterior
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
420 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Received pericardiotomy
Arm Type
Experimental
Arm Description
Patient will receive a posterior left pericardiotomy at the time of surgery
Arm Title
No Pericardiotomy
Arm Type
No Intervention
Arm Description
Patient will not receive posterior left pericardiotomy.
Intervention Type
Procedure
Intervention Name(s)
Posterior left pericardiotomy
Intervention Description
Patient will receive a posterior left sided pericardiotomy. The incision will be made posterior to the phrenic nerve and run from the inferior left pulmonary vein to the diaphragm.
Primary Outcome Measure Information:
Title
Number of participants that experience Postoperative Atrial Fibrillation (POAF)
Description
POAF occurrences are defined as any irregular heart rhythm, without detectable P-wave, that lasts more than 30 seconds.
Time Frame
During hospitalization, approximately 5 days
Secondary Outcome Measure Information:
Title
Duration of Postoperative Atrial Fibrillation (POAF)
Description
Time spent in atrial fibrillation (seconds), defined as the time from the first evidence of atrial fibrillation to the first evidence of sinus rhythm restoration on cardiac monitoring strips or standard electrocardiograms (EKG)
Time Frame
During hospitalization, approximately 5 days
Title
Duration of Hospitalization
Description
Time (hours) spent in hospital after surgery completion
Time Frame
During hospitalization, up to 100 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
all consecutive patients admitted to the department of cardiothoracic surgery of the NYPH-WCMC will be screened for enrollment.
Exclusion Criteria:
preoperative non-sinus rhythm
history of previous atrial arrhythmia of any type
reoperations
mitral or tricuspid valve disease
surgery of the descending thoracic or thoracoabdominal aorta
need for hypothermic circulatory arrest
off pump operation
urgent/emergent presentation
disease of the left pleura or previous left thoracotomy
chest deformity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonard N Girardi, MD
Organizational Affiliation
Weill Cornell Medical College New York Presbyterian Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mario F Gaudino, MD
Organizational Affiliation
Weill Cornell Medical College New York Presbyterian Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Weil Cornell Medical College Department of Cardiothoracic Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
19691996
Citation
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.
Results Reference
result
PubMed Identifier
22235005
Citation
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.
Results Reference
result
PubMed Identifier
34788640
Citation
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.
Results Reference
derived
PubMed Identifier
29237510
Citation
Abouarab AA, Leonard JR, Ohmes LB, Lau C, Rong LQ, Ivascu NS, Pryor KO, Munjal M, Crea F, Massetti M, Sanna T, Girardi LN, Gaudino M. Posterior Left pericardiotomy for the prevention of postoperative Atrial fibrillation after Cardiac Surgery (PALACS): study protocol for a randomized controlled trial. Trials. 2017 Dec 13;18(1):593. doi: 10.1186/s13063-017-2334-4.
Results Reference
derived
Links:
URL
http://www.cornellheartsurgery.org/
Description
Weill Cornell Department of Cardiothoracic Surgery
Learn more about this trial
The Effect of Posterior Pericardiotomy on the Incidence of Atrial Fibrillation After Cardiac Surgery
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