Evaluation Of New Onset Postoperative Atrial Fibrillation

Completed · Not applicable

Conditions studied: Atrial Fibrillation New Onset

In brief

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.

Key facts

Study ID

NCT01247974

Run by

Elutia Inc.

People needed

439

Starts

2010-12-01

Expected to finish

2012-12-01

Last updated by the study team

2023-07-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• St. Luke's Hospital — Kansas City, Missouri, United States
• Columbia University Medical Center — New York, New York, United States
• The Ohio State University Medical Center — Columbus, Ohio, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Baptist Memorial Hospital — Memphis, Tennessee, United States
• Swedish Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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