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Evaluation Of New Onset Postoperative Atrial Fibrillation

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
CorMatrix Cardiovascular, Inc.
ClinicalTrials.gov Identifier:
NCT01247974
First received: November 23, 2010
Last updated: March 9, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention
New Onset Postoperative Atrial Fibrillation
 Device: CorMatrix® ECM® for Pericardial Closure
Other: No Pericardial Closure

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: PROSPECTIVE, RANDOMIZED EVALUATION OF NEW ONSET POSTOPERATIVE ATRIAL FIBRILLATION IN SUBJECTS RECEIVING THE CORMATRIX® ECM® FOR PERICARDIAL CLOSURE

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by CorMatrix Cardiovascular, Inc.:

Primary Outcome Measures:
  • Primary Safety Endpoint [ Time Frame: 30 days postprocedure ] [ Designated as safety issue: Yes ]
    A composite endpoint consisting of procedure-related serious adverse events occurring within 30 days postprocedure.

  • Primary Effectiveness Endpoint [ Time Frame: 7 days postoperatively or hospital discharge, whichever is sooner ] [ Designated as safety issue: No ]
    Rate of new onset postoperative atrial fibrillation during the first seven days postoperatively or prior hospital discharge, whichever is sooner.


Secondary Outcome Measures:
  • Secondary Safety Endpoint [ Time Frame: 270 days postprocedure ] [ Designated as safety issue: Yes ]
    A composite measure of bypass graft failure consisting of procedure-related events occurring beyond 30 days and within 270 days postprocedure.

  • Secondary Effectiveness Endpoint [ Time Frame: 7 days postoperatively or hospital discharge, whichever is sooner ] [ Designated as safety issue: No ]
    Rate of treated or sustained episodes of new onset postoperative atrial fibrillation during the first seven days postoperatively or prior to hospital discharge, whichever is sooner.

  • Secondary Effectiveness Endpoint [ Time Frame: 7 days postoperatively or hospital discharge, whichever is sooner ] [ Designated as safety issue: No ]
    Rate of treated episodes of new onset postoperative atrial fibrillation during the first seven days postoperatively or prior to hospital discharge, whichever is sooner.


Enrollment: 440
Study Start Date: December 2010
Estimated Study Completion Date: December 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CorMatrix® ECM® Device: CorMatrix® ECM® for Pericardial Closure
Circumferential closure of the pericardium following CABG surgery using the CorMatrix ECM for Pericardial Closure
No Intervention: No Pericardial Closure Other: No Pericardial Closure
No closure of the pericardium following CABG surgery.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01247974

Locations
United States, Alabama
Trinity Medical Center
Birmingham, Alabama, United States, 35213
Southeast Alabama Medical Center
Dothan, Alabama, United States, 36301
Mobile Infirmary Medical Center
Mobile, Alabama, United States, 36607
Providence Hospital
Mobile, Alabama, United States, 36608
United States, California
Saint Agnes Medical Center
Fresno, California, United States, 93720
Stanford University School of Medicine
Stanford, California, United States, 94305
United States, Florida
St. Vincent's Hospital
Jacksonville, Florida, United States, 32204
Florida Hospital
Orlando, Florida, United States, 32803
United States, Illinois
Advocate Christ Medical Center
Oak Lawn, Illinois, United States, 60453
United States, Indiana
Saint Francis Heart Center
Indianapolis, Indiana, United States, 46237
United States, Missouri
St. Luke's Hospital
Kansas City, Missouri, United States, 64111
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, Ohio
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Baptist Memorial Hospital
Memphis, Tennessee, United States, 38120
United States, Washington
Swedish Medical Center
Seattle, Washington, United States, 98122
Sponsors and Collaborators
CorMatrix Cardiovascular, Inc.
Investigators
Principal Investigator: Marc Gerdisch, M.D. St. Francis Heart Center
  More Information

No publications provided

Responsible Party: CorMatrix Cardiovascular, Inc.
ClinicalTrials.gov Identifier: NCT01247974     History of Changes
Other Study ID Numbers: 08-PR-1006
Study First Received: November 23, 2010
Last Updated: March 9, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by CorMatrix Cardiovascular, Inc.:
Coronary Artery Bypass Grafting
New Onset Postoperative Atrial Fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013