Prospective, Randomized Evaluation of New Onset Postoperative Atrial Fibrillation in Subjects Receiving the CorMatrix® ECM® for Pericardial Closure
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Aziyo Biologics, Inc.
- Enrollment
- 439
- Locations
- 31
- Primary Endpoint
- Primary Effectiveness Endpoint
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Primary Effectiveness Endpoint
Time Frame: 7 days postoperatively or hospital discharge, whichever is sooner
Rate of new onset postoperative atrial fibrillation during the first seven days postoperatively or prior to hospital discharge, whichever was sooner.
Primary Safety Endpoint
Time Frame: 30 days postprocedure
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)
Secondary Outcomes
No secondary outcomes reported