Status:
COMPLETED
Evaluation Of New Onset Postoperative Atrial Fibrillation
Lead Sponsor:
Elutia Inc.
Conditions:
Atrial Fibrillation New Onset
Eligibility:
All Genders
18+ years
Phase:
NA
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 postop...
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 fibril...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
439 Patients enrolled
Trial Details
Trial ID
NCT01247974
Start Date
December 1 2010
End Date
December 1 2012
Last Update
July 27 2023
Active Locations (16)
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1
Trinity Medical Center
Birmingham, Alabama, United States, 35213
2
Southeast Alabama Medical Center
Dothan, Alabama, United States, 36301
3
Mobile Infirmary Medical Center
Mobile, Alabama, United States, 36607
4
Providence Hospital
Mobile, Alabama, United States, 36608