Evaluation Of New Onset Postoperative Atrial Fibrillation
NCT ID: NCT01247974
Last Updated: 2023-07-27
Study Results
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View full resultsBasic Information
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COMPLETED
NA
439 participants
INTERVENTIONAL
2010-12-31
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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CorMatrix ECM for Pericardial Closure
Pericardial closure with CorMatrix ECM
CorMatrix ECM for Pericardial Closure
Circumferential closure of the pericardium following CABG surgery using the CorMatrix ECM for Pericardial Closure
Control
No Pericardial Closure
No interventions assigned to this group
Interventions
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CorMatrix ECM for Pericardial Closure
Circumferential closure of the pericardium following CABG surgery using the CorMatrix ECM for Pericardial Closure
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Elutia Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Marc Gerdisch, M.D.
Role: PRINCIPAL_INVESTIGATOR
St. Francis Heart Center
Locations
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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
Countries
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Other Identifiers
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08-PR-1006
Identifier Type: -
Identifier Source: org_study_id
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