The Effect of Posterior Pericardiotomy on the Incidence of Atrial Fibrillation After Cardiac Surgery

NCT02875405 | Completed DMC

• 1 other identifier: 1502015867
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if preforming a posterior left pericardiotomy prevents atrial fibrillation after cardiac surgery.

Conditions

Atrial Fibrillation

Keywords

postoperative; pericardiotomy; prevention; cardiac surgery; left; posterior

Outcome Measures

Primary Outcomes (1)

• 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.

  During hospitalization, approximately 5 days

Secondary Outcomes (2)

• Duration of Postoperative Atrial Fibrillation (POAF)

  During hospitalization, approximately 5 days

• Duration of Hospitalization

  During hospitalization, up to 100 days after surgery

Study Arms (2)

Received pericardiotomy

EXPERIMENTAL

Patient will receive a posterior left pericardiotomy at the time of surgery

Procedure: Posterior left pericardiotomy

No Pericardiotomy

NO INTERVENTION

Patient will not receive posterior left pericardiotomy.

Interventions

Posterior left pericardiotomy PROCEDURE

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.

Received pericardiotomy

Eligibility Criteria

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

You may qualify if:

• all consecutive patients admitted to the department of cardiothoracic surgery of the NYPH-WCMC will be screened for enrollment.

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Catholic University of the Sacred Heart: collaborator

Study Sites (1)

Weil Cornell Medical College Department of Cardiothoracic Surgery

New York, New York, 10065, United States

Location

Related Publications (6)

• 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 RESULT

• 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 RESULT

• 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

• Rong LQ, Di Franco A, Rahouma M, Dimagli A, Chan J, Lopes AJ, Kim J, Sanna T, Devereux RB, Delgado V, Weinsaft JW, Crea F, Alexander JH, Gillinov M, DiMaio JM, Pryor KO, Girardi L, Gaudino M. Postoperative pericardial effusion, pericardiotomy, and atrial fibrillation: An explanatory analysis of the PALACS trial. Am Heart J. 2023 Jun;260:113-123. doi: 10.1016/j.ahj.2023.03.001. Epub 2023 Mar 18.

  PMID: 36934978 DERIVED

• 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 DERIVED

• 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.

  PMID: 29237510 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 F Gaudino, MD

  Weill Cornell Medical College New York Presbyterian Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2016
• First Posted: August 23, 2016
• Study Start: September 20, 2017
• Primary Completion: August 10, 2021
• Study Completion: August 24, 2021
• Last Updated: August 27, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)