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Trial record 1 of 1 for:    NCT02875405
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The Effect of Posterior Pericardiotomy on the Incidence of Atrial Fibrillation After Cardiac Surgery (PALACS)

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ClinicalTrials.gov Identifier: NCT02875405
Recruitment Status : Recruiting
First Posted : August 23, 2016
Last Update Posted : July 10, 2019
Sponsor:
Collaborator:
Catholic University of the Sacred Heart
Information provided by (Responsible Party):
Weill Medical College of Cornell University

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

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Procedure: Posterior left pericardiotomy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: The Effect of Posterior Pericardiotomy on the Incidence of Atrial Fibrillation After Cardiac Surgery
Actual Study Start Date : September 20, 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Received pericardiotomy
Patient will receive a posterior left pericardiotomy at the time of surgery
Procedure: Posterior left pericardiotomy
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.

No Intervention: No Pericardiotomy
Patient will not receive posterior left pericardiotomy.



Primary Outcome Measures :
  1. Number of participants that experience Postoperative Atrial Fibrillation (POAF) [ Time Frame: During hospitalization, approximately 5 days ]
    POAF occurrences are defined as any irregular heart rhythm, without detectable P-wave, that lasts more than 30 seconds.


Secondary Outcome Measures :
  1. Duration of Postoperative Atrial Fibrillation (POAF) [ Time Frame: During hospitalization, approximately 5 days ]
    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)

  2. Duration of Hospitalization [ Time Frame: During hospitalization, up to 100 days after surgery ]
    Time (hours) spent in hospital after surgery completion



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02875405


Contacts
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Contact: Mario FL Gaudino, MD 212-746-5460 mfg9004@med.cornell.edu
Contact: Jeremy R Leonard, MD 212-746-5460 jel2038@nyp.org

Locations
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United States, New York
Weil Cornell Medical College Department of Cardiothoracic Surgery Recruiting
New York, New York, United States, 10065
Contact: Mario F Gaudino, MD    212-746-1815    mfg9004@med.cornell.edu   
Contact: Nathan T Palaparthi, MS    212-746-5194    ntp2001@med.cornell.edu   
Sponsors and Collaborators
Weill Medical College of Cornell University
Catholic University of the Sacred Heart
Investigators
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Principal Investigator: Leonard N Girardi, MD Weill Cornell Medical College New York Presbyterian Hospital
Study Chair: Mario F Gaudino, MD Weill Cornell Medical College New York Presbyterian Hospital

Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT02875405     History of Changes
Other Study ID Numbers: 1502015867
First Posted: August 23, 2016    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Weill Medical College of Cornell University:
postoperative
pericardiotomy
prevention
cardiac surgery
left
posterior

Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes