Safety and Efficacy Study of Amniotic Membrane Patch to Treat Postoperative Atrial Fibrillation

Study Overview
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Brief Summary
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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.

Detailed Description
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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 can put patients at clinical risk for stroke and other arrhythmias. NOPAF commonly prolongs hospitalization leading to increased use of hospital resources, higher cost and decreased patient satisfaction. A number of risk factors have been associated with the development of NOPAF including age, prior history of atrial fibrillation, Chronic Obstructive Pulmonary Disease (COPD), chronic renal failure, diabetes and obesity. It is not entirely clear what causes NOPAF; the prevailing theory is that it is a multi-factorial process, possibly due in part to inflammation from the surgery. The usual treatments for NOPAF are associated with various side effects and risks. We propose to test the hypothesis that an amniotic membrane patch, with minimal known risk and side effects, placed on the heart's surface during surgery will reduce the incidence of NOPAF. This phase I/II prospective, single-center, randomized controlled clinical trial is being undertaken to assess the safety of the amniotic membrane patch when used in the setting of CABG surgery and whether utilization of the amniotic membrane patch to aid repair of the normal epicardium following isolated, first-time CABG procedures might result in a lower rate of NOPAF compared to subjects who did not undergo treatment with the amniotic membrane patch.

Official Title
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Prospective, Randomized Evaluation of New Onset Postoperative Atrial Fibrillation in Subjects Receiving an Amniotic Membrane Patch Placed on the Epicardial Surface

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Biological: Amniotic Membrane Patch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Amniotic membrane patch placement<br>One amniotic membrane patch will be placed on the epicardial surface of the heart immediately following a CABG procedure prior to wound closure. | Biological: Amniotic Membrane Patch<br> <br> * Other names: PalinGen Kardia XPlus Membrane;|
| No Intervention: Control<br>Amniotic membrane patch will not be placed after CABG procedure prior to wound closure. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of new onset postoperative atrial fibrillation |  | up to 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure-related serious adverse events |  | up to 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial Fibrillation, Amniotic Membrane