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

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Procedure: Posterior left pericardiotomy

• Registration Number: NCT02875405
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-07-25
• Study First Submitted QC: 2016-08-22
• Study First Posted: 2016-08-23
• Study Start: 2017-09-20
• Status Verified: 2021-08
• Primary Completion: 2021-08-10
• Study Completion: 2021-08-24
• Last Update Submitted: 2021-08-26
• Last Update Posted: 2021-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 420

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Received pericardiotomy	Posterior left pericardiotomy	Patient will receive a posterior left pericardiotomy at the time of surgery

Primary Outcome Measures

Name	Time	Method
Number of participants that experience Postoperative Atrial Fibrillation (POAF)	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

Name	Time	Method
Duration of Postoperative Atrial Fibrillation (POAF)	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)
Duration of Hospitalization	During hospitalization, up to 100 days after surgery	Time (hours) spent in hospital after surgery completion

Trial Locations

Locations (1)

Weil Cornell Medical College Department of Cardiothoracic Surgery; 🇺🇸 New York, New York, United States