Evaluation Of New Onset Postoperative Atrial Fibrillation

Aziyo Biologics

Status

Completed

Conditions

Atrial Fibrillation New Onset

Treatments

Device: CorMatrix ECM for Pericardial Closure

Study type

Interventional

Funder types

Industry

Identifiers

NCT01247974

08-PR-1006

Details and patient eligibility

About

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.

Full 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.

Enrollment

439 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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