Evaluation Of New Onset Postoperative Atrial Fibrillation

Not Applicable

Completed

Brief Summary: This is a multi-center, prospective, randomized and controlled clinical trial comparing the safety and efficacy of the CorMatrix ECM for Pericardial Closure to reduce the incidence of new onset postoperative atrial fibrillation by circumferentially reconstructing the normal pericardial anatomy following isolated, first-time, CABG procedures compared to subjects that do not undergo pericardial closure. This trial will be conducted at up to 20 clinical sites in the U.S.

Detailed Description: The objective of this prospective clinical trial is to demonstrate the safety and efficacy of the CorMatrix ECM for Pericardial Closure to reduce the incidence of new onset postoperative atrial fibrillation by circumferentially reconstructing the normal pericardial anatomy following isolated, first-time, coronary artery bypass grafting (CABG) procedures as compared to subjects who did not undergo pericardial closure. Safety will be established by demonstrating that the composite clinical event rate for the ECM treatment group is not worse than the control group that did not undergo pericardial closure. The efficacy will be established by demonstrating a reduced incidence of new onset postoperative atrial fibrillation in the ECM treatment group as compared to the control group.

Recruitment & Eligibility

Inclusion Criteria

The subject is 18 years of age or older
This cardiac operation is the subject's first or primary cardiac operation
The subject must be undergoing an isolated CABG procedure using a median sternotomy approach
The subject must possess the ability to provide written Informed Consent
The subject must express a willingness to fulfill all of the expected requirements of this clinical protocol

Exclusion Criteria

Prior history of atrial fibrillation
Prior history of open heart surgery
Prior history of pericarditis
Prior history of anti-arrhythmia drug treatment (e.g., amiodarone, dronedarone or sotalol) in the past six months
The subject has an implantable cardiac device (i.e., cardiac resynchronization therapy devices with and without defibrillator capabilities (CRTs and CRT-Ds), implantable cardioverter-defibrillators (ICD) and pacemakers)
Concomitant procedure planned
In the investigator's opinion, the subject may require prophylactic treatment with anti-arrhythmia drugs or temporary pacing postoperatively

Primary Outcome Measures

Name	Time	Method
Primary Effectiveness Endpoint	7 days postoperatively or hospital discharge, whichever is sooner	Rate of new onset postoperative atrial fibrillation during the first seven days postoperatively or prior to hospital discharge, whichever was sooner.
Primary Safety Endpoint	30 days postprocedure	A composite endpoint consisting of the following procedure- related serious adverse events occurring within 30 days postprocedure: * Death * Myocardial Infarction (MI) * Stroke * Mediastinal Reoperation * Percutaneous Coronary Intervention (PCI)

Secondary Outcome Measures

Name	Time	Method

Locations (16): Trinity Medical Center
🇺🇸
Birmingham, Alabama, United States
Southeast Alabama Medical Center
🇺🇸
Dothan, Alabama, United States
Mobile Infirmary Medical Center
🇺🇸
Mobile, Alabama, United States
Providence Hospital
🇺🇸
Mobile, Alabama, United States
Saint Agnes Medical Center
🇺🇸
Fresno, California, United States
Stanford University School of Medicine
🇺🇸
Stanford, California, United States
St. Vincent's Hospital
🇺🇸
Jacksonville, Florida, United States
Florida Hospital
🇺🇸
Orlando, Florida, United States
Advocate Christ Medical Center
🇺🇸
Oak Lawn, Illinois, United States
Saint Francis Heart Center
🇺🇸
Indianapolis, Indiana, United States
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Trinity Medical Center
🇺🇸Birmingham, Alabama, United States