Atrial Fibrillation New Onset
Conditions
Keywords
Coronary Artery Bypass Grafting, New Onset Postoperative Atrial Fibrillation
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.
Interventions
DEVICECorMatrix ECM for Pericardial Closure
Circumferential closure of the pericardium following CABG surgery using the CorMatrix ECM for Pericardial Closure
Sponsors
Elutia Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety Endpoint | 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) |
| Primary Effectiveness Endpoint | 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. |
Countries
United States
Participant flow
Pre-assignment details
One subject, Subject 011-006, was randomized in error to the ECM treatment group, but did not provide informed consent. This deviation was discovered prior to the surgery.
Participants by arm
| Arm | Count |
|---|---|
| CorMatrix® ECM® CorMatrix® ECM® for Pericardial Closure: Circumferential closure of the pericardium following CABG surgery using the CorMatrix ECM for Pericardial Closure | 217 |
| Control No closure of pericardium | 222 |
| Total | 439 |
Baseline characteristics
| Characteristic | CorMatrix® ECM® | Control | Total |
|---|---|---|---|
| Age, Customized 18Y and older | 217 participants | 222 participants | 439 participants |
| Region of Enrollment United States | 217 participants | 222 participants | 439 participants |
| Sex: Female, Male Female | 51 Participants | 53 Participants | 104 Participants |
| Sex: Female, Male Male | 166 Participants | 169 Participants | 335 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 190 / 208 | 189 / 220 |
| serious Total, serious adverse events | 76 / 208 | 54 / 220 |
Outcome results
Primary
Primary Effectiveness Endpoint
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
Population: Primary analysis was based upon the ITT population using multiple imputation to impute missing values. The ITT population was defined as all subjects who provided informed consent and were randomized in the trial.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CorMatrix ECM for Pericardial Closure | Primary Effectiveness Endpoint | 40.0 percentage of participants |
| Control | Primary Effectiveness Endpoint | 35.9 percentage of participants |
Primary
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)
Time frame: 30 days postprocedure
Population: Performed with the FAS population using multiple imputation methods to impute values for missing or incomplete data. FAS population was defined as subjects in the ITT population who had CABG surgery and received their assigned treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CorMatrix ECM for Pericardial Closure | Primary Safety Endpoint | 3.9 percentage of participants |
| Control | Primary Safety Endpoint | 3.6 percentage of participants |