Evaluation Of New Onset Postoperative Atrial Fibrillation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective, Randomized Evaluation of New Onset Postoperative Atrial Fibrillation in Subjects Receiving the CorMatrix® ECM® for Pericardial Closure

Conditions
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Atrial Fibrillation New Onset

Intervention / Treatment
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* Device: CorMatrix ECM for Pericardial Closure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CorMatrix ECM for Pericardial Closure<br>Pericardial closure with CorMatrix ECM | Device: CorMatrix ECM for Pericardial Closure<br>* Circumferential closure of the pericardium following CABG surgery using the CorMatrix ECM for Pericardial Closure<br>|
| No Intervention: Control<br>No Pericardial Closure | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Safety Endpoint | 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) | 30 days postprocedure | 
| Primary Effectiveness Endpoint | Rate of new onset postoperative atrial fibrillation during the first seven days postoperatively or prior to hospital discharge, whichever was sooner. | 7 days postoperatively or hospital discharge, whichever is sooner | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Artery Bypass Grafting, New Onset Postoperative Atrial Fibrillation