Evaluation Of New Onset Postoperative Atrial Fibrillation

Elutia Inc.439 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

439

Conditions

Atrial Fibrillation New Onset

Interventions

CorMatrix ECM for Pericardial ClosureDEVICE

Circumferential closure of the pericardium following CABG surgery using the CorMatrix ECM for Pericardial Closure

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (16)

Trinity Medical Center

Birmingham, Alabama, United States

Southeast Alabama Medical Center

Dothan, Alabama, United States

Outcomes

Primary Outcomes

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)

Time frame: 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.

Time frame: 7 days postoperatively or hospital discharge, whichever is sooner

Data from ClinicalTrials.gov

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