N/A
N=439
Evaluation Of New Onset Postoperative Atrial Fibrillation
Atrial Fibrillation New Onset
Bottom Line
View on ClinicalTrials.gov: NCT01247974 ↗Enrolled (actual)
439
Serious AEs
30.4%
Results posted
Sep 2015
Primary outcome: Primary: Primary Safety Endpoint — 3.9; 3.6 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CorMatrix ECM for Pericardial Closure (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Elutia Inc.
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Safety Endpoint |
3.9; 3.6 | — |
| PRIMARY Primary Effectiveness Endpoint |
40.0; 35.9 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01247974). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.