Clinical trial NCT01247974: Evaluation Of New Onset Postoperative Atrial Fibrillation
Official title: Prospective, Randomized Evaluation of New Onset Postoperative Atrial Fibrillation in Subjects Receiving the CorMatrix® ECM® for Pericardial Closure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation New Onset
Keywords: Coronary Artery Bypass Grafting
New Onset Postoperative Atrial Fibrillation
Lead sponsor: Elutia Inc.
Sponsor class: INDUSTRY
First posted: 2010-11-25
Enrollment: 439
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Primary Safety Endpoint
timeFrame: 30 days postprocedure
measure: Primary Effectiveness Endpoint
timeFrame: 7 days postoperatively or hospital discharge, whichever is sooner
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Trinity Medical Center
state: Alabama
city: Dothan
country: United States
facility: Southeast Alabama Medical Center
state: Alabama
city: Mobile
country: United States
facility: Mobile Infirmary Medical Center
state: Alabama
city: Mobile
country: United States
facility: Providence Hospital
state: Alabama
city: Fresno
country: United States
facility: Saint Agnes Medical Center
state: California
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: Jacksonville
country: United States
facility: St. Vincent's Hospital
state: Florida
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Oak Lawn
country: United States
facility: Advocate Christ Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Saint Francis Heart Center
state: Indiana
city: Kansas City
country: United States
facility: St. Luke's Hospital
state: Missouri
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Columbus
country: United States
facility: The Ohio State University Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Memphis
country: United States
facility: Baptist Memorial Hospital
state: Tennessee
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
Study officials:
affiliation: St. Francis Heart Center
name: Marc Gerdisch, M.D.
role: PRINCIPAL_INVESTIGATOR
References: