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
1 other identifier
interventional
439
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2010
Typical duration for not_applicable
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 23, 2010
CompletedFirst Posted
Study publicly available on registry
November 25, 2010
CompletedStudy Start
First participant enrolled
December 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedResults Posted
Study results publicly available
September 16, 2015
CompletedJuly 27, 2023
July 1, 2023
2 years
November 23, 2010
February 13, 2014
July 19, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
CorMatrix ECM for Pericardial Closure
EXPERIMENTALPericardial closure with CorMatrix ECM
Control
NO INTERVENTIONNo Pericardial Closure
Interventions
Circumferential closure of the pericardium following CABG surgery using the CorMatrix ECM for Pericardial Closure
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Elutia Inc.lead
Study Sites (16)
Trinity Medical Center
Birmingham, Alabama, 35213, United States
Southeast Alabama Medical Center
Dothan, Alabama, 36301, United States
Mobile Infirmary Medical Center
Mobile, Alabama, 36607, United States
Providence Hospital
Mobile, Alabama, 36608, United States
Saint Agnes Medical Center
Fresno, California, 93720, United States
Stanford University School of Medicine
Stanford, California, 94305, United States
St. Vincent's Hospital
Jacksonville, Florida, 32204, United States
Florida Hospital
Orlando, Florida, 32803, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453, United States
Saint Francis Heart Center
Indianapolis, Indiana, 46237, United States
St. Luke's Hospital
Kansas City, Missouri, 64111, United States
Columbia University Medical Center
New York, New York, 10032, United States
The Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Baptist Memorial Hospital
Memphis, Tennessee, 38120, United States
Swedish Medical Center
Seattle, Washington, 98122, United States
Results Point of Contact
- Title
- Director, Clinical Development
- Organization
- CorMatrix Cardiovascular
Study Officials
- PRINCIPAL INVESTIGATOR
Marc Gerdisch, M.D.
St. Francis Heart Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 23, 2010
First Posted
November 25, 2010
Study Start
December 1, 2010
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
July 27, 2023
Results First Posted
September 16, 2015
Record last verified: 2023-07