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Evaluation Of New Onset Postoperative Atrial Fibrillation

Primary Purpose

Atrial Fibrillation New Onset

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CorMatrix ECM for Pericardial Closure
Sponsored by
Aziyo Biologics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation New Onset focused on measuring Coronary Artery Bypass Grafting, New Onset Postoperative Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Trinity Medical Center
  • Southeast Alabama Medical Center
  • Mobile Infirmary Medical Center
  • Providence Hospital
  • Saint Agnes Medical Center
  • Stanford University School of Medicine
  • St. Vincent's Hospital
  • Florida Hospital
  • Advocate Christ Medical Center
  • Saint Francis Heart Center
  • St. Luke's Hospital
  • Columbia University Medical Center
  • The Ohio State University Medical Center
  • Hospital of the University of Pennsylvania
  • Baptist Memorial Hospital
  • Swedish Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CorMatrix ECM for Pericardial Closure

Control

Arm Description

Pericardial closure with CorMatrix ECM

No Pericardial Closure

Outcomes

Primary Outcome Measures

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)
Primary Effectiveness Endpoint
Rate of new onset postoperative atrial fibrillation during the first seven days postoperatively or prior to hospital discharge, whichever was sooner.

Secondary Outcome Measures

Full Information

First Posted
November 23, 2010
Last Updated
July 19, 2023
Sponsor
Aziyo Biologics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01247974
Brief Title
Evaluation Of New Onset Postoperative Atrial Fibrillation
Official Title
Prospective, Randomized Evaluation of New Onset Postoperative Atrial Fibrillation in Subjects Receiving the CorMatrix® ECM® for Pericardial Closure
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aziyo Biologics, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation New Onset
Keywords
Coronary Artery Bypass Grafting, New Onset Postoperative Atrial Fibrillation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
439 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CorMatrix ECM for Pericardial Closure
Arm Type
Experimental
Arm Description
Pericardial closure with CorMatrix ECM
Arm Title
Control
Arm Type
No Intervention
Arm Description
No Pericardial Closure
Intervention Type
Device
Intervention Name(s)
CorMatrix ECM for Pericardial Closure
Intervention Description
Circumferential closure of the pericardium following CABG surgery using the CorMatrix ECM for Pericardial Closure
Primary Outcome Measure Information:
Title
Primary Safety Endpoint
Description
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
Title
Primary Effectiveness Endpoint
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Gerdisch, M.D.
Organizational Affiliation
St. Francis Heart Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Trinity Medical Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35213
Country
United States
Facility Name
Southeast Alabama Medical Center
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36301
Country
United States
Facility Name
Mobile Infirmary Medical Center
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36607
Country
United States
Facility Name
Providence Hospital
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Saint Agnes Medical Center
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
St. Vincent's Hospital
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Florida Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Advocate Christ Medical Center
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
Saint Francis Heart Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
St. Luke's Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
The Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Baptist Memorial Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States

12. IPD Sharing Statement

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Evaluation Of New Onset Postoperative Atrial Fibrillation

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