Evaluation Of New Onset Postoperative Atrial Fibrillation

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

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation New Onset
• Intervention / Treatment: Device: CorMatrix ECM for Pericardial Closure

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.

• Study Type: Interventional
• Enrollment (Actual): 439
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35213
      • Trinity Medical Center
    • Dothan, Alabama, United States, 36301
      • Southeast Alabama Medical Center
    • Mobile, Alabama, United States, 36608
      • Providence Hospital
    • Mobile, Alabama, United States, 36607
      • Mobile Infirmary Medical Center
  • California
    • Fresno, California, United States, 93720
      • Saint Agnes Medical Center
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine
  • Florida
    • Jacksonville, Florida, United States, 32204
      • St. Vincent's Hospital
    • Orlando, Florida, United States, 32803
      • Florida Hospital
  • Illinois
    • Oak Lawn, Illinois, United States, 60453
      • Advocate Christ Medical Center
  • Indiana
    • Indianapolis, Indiana, United States, 46237
      • Saint Francis Heart Center
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • St. Luke's Hospital
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • Baptist Memorial Hospital
  • Washington
    • Seattle, Washington, United States, 98122
      • Swedish Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CorMatrix ECM for Pericardial Closure; Pericardial closure with CorMatrix ECM	Device: CorMatrix ECM for Pericardial Closure; Circumferential closure of the pericardium following CABG surgery using the CorMatrix ECM for Pericardial Closure
No Intervention: Control; No Pericardial Closure

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Aziyo Biologics, Inc.
• Investigators: Principal Investigator: Marc Gerdisch, M.D., St. Francis Heart Center

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: November 23, 2010
• First Submitted That Met QC Criteria: November 23, 2010
• First Posted (Estimated): November 25, 2010

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 19, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Coronary Artery Bypass Grafting; New Onset Postoperative Atrial Fibrillation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 08-PR-1006