Safety and Efficacy Study of Amniotic Membrane Patch to Treat Postoperative Atrial Fibrillation
Withdrawn before enrolling · Phase 1/Phase 2
Conditions studied: Atrial Fibrillation
In brief
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 subjects who did not undergo epicardium intervention.
Key facts
- Study ID
- NCT02193321
- Run by
- University of Arizona
- People needed
- 0
- Starts
- 2014-07-01
- Expected to finish
- 2015-07-01
- Last updated by the study team
- 2015-12-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 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
- Intraoperative Exclusion Criteria:
- Unexpected procedure (i.e., valve repair/replacement) or intraoperative findings creating an unreasonable intraoperative risk or an increased probability of postoperative complications in terms of recovery.
- CABG procedure with > 3 hours total on (cardiopulmonary bypass) CPB.
- Prophylactic use of amiodarone.
- Postoperative Exclusion Criteria:
- Prophylactic use of amiodarone
- No prophylactic, temporary pacing except for symptomatic bradycardia or advanced heart black as defined as:
- Sinus bradycardia < 40 beats per minute
- Type 1 atrioventricular (AV) block
- Type 2 AV block
- Complete block
Where it is running
- University of Arizona Medical Center — Tucson, Arizona, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.