Evaluation Of New Onset Postoperative Atrial Fibrillation

Atrial Fibrillation New Onset Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01247974
• Other study ID #: 08-PR-1006
• Status: Completed
• Phase: N/A
• Start date: December 2010
• Est. completion date: December 2012

Study information

• Verified date: July 2023
• Source: Aziyo Biologics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 439
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation New Onset

Intervention

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

Locations

Country	Name	City	State
United States	Trinity Medical Center	Birmingham	Alabama
United States	The Ohio State University Medical Center	Columbus	Ohio
United States	Southeast Alabama Medical Center	Dothan	Alabama
United States	Saint Agnes Medical Center	Fresno	California
United States	Saint Francis Heart Center	Indianapolis	Indiana
United States	St. Vincent's Hospital	Jacksonville	Florida
United States	St. Luke's Hospital	Kansas City	Missouri
United States	Baptist Memorial Hospital	Memphis	Tennessee
United States	Mobile Infirmary Medical Center	Mobile	Alabama
United States	Providence Hospital	Mobile	Alabama
United States	Columbia University Medical Center	New York	New York
United States	Advocate Christ Medical Center	Oak Lawn	Illinois
United States	Florida Hospital	Orlando	Florida
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Swedish Medical Center	Seattle	Washington
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Aziyo Biologics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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