Status:
WITHDRAWN
Safety and Efficacy Study of Amniotic Membrane Patch to Treat Postoperative Atrial Fibrillation
Lead Sponsor:
University of Arizona
Collaborating Sponsors:
PalinGen
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to to evaluate the rate of new onset postoperative atrial fibrillation in subjects receiving the amniotic membrane patch placed on the epicardial surface as compared to su...
Detailed Description
New onset postoperative atrial fibrillation (NOPAF) presents in approximately 27 to 40% of patients who have recently undergone coronary artery bypass graft (CABG) or other open heart surgeries. NOPAF...
Eligibility Criteria
Inclusion
- 18 years 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
- Must have ability to provide written informed consent
- Must have ability to fulfill all of the expected requirements of this clinical protocol
- Preoperative
Exclusion
- 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
- Intraoperative
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02193321
Start Date
July 1 2014
End Date
July 1 2015
Last Update
December 2 2015
Active Locations (1)
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1
University of Arizona Medical Center
Tucson, Arizona, United States, 85724