CardiaMend and Amiodarone for the Prevention of POAF

Study Overview
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Brief Summary
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The principal purpose of this investigator-initiated trial is to study the use of the CardiaMend device soaked in the anti-arrhythmic drug amiodarone, and how it may decrease the development of atrial fibrillation in patients that have undergone a coronary artery bypass surgery, or isolated valve surgery.

Official Title
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A Prospective Pilot Study of the Combination of CardiaMend and Amiodarone for the Prevention of Postoperative Atrial Fibrillation (POAF) in Patients Undergoing Isolated Coronary Artery Bypass Grafting or Isolated Valve Surgery

Conditions
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POAF, Atrial Fibrillation

Intervention / Treatment
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* Combination Product: CardiaMend with antiarrhythmic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 21-85 years Able to provide written informed consent, understand and be willing to comply with study-related procedures. Scheduled to undergo open-chest cardiac surgery via complete median sternotomy for coronary artery bypass graft (CABG), or isolated valve repair/replacement. Inclusionary valve repair/replacement procedures with the primary reason for surgery inclusive of aortic valve repair/replacement or mitral valve repair/replacement. Left atrial appendage (LAA) procedures are allowed if CABG and/or valve repair or replacement is the qualifying surgical procedure, but is not a qualifying surgical procedure on its own. In sinus rhythm at the time of consultation and on a previous EKG, or no history of atrial fibrillation (note: continuous ECG monitoring for 48 hours is not required) Exclusion Criteria: Unable to give voluntary written informed consent, is unlikely to cooperate or is legally incompetent, including subjects who are institutionalized by court or official order, or in a dependency relationship with testing center or investigator. Any condition which could interfere with the subject's ability to comply with the study. Ongoing participation in an interventional clinical study or during the preceding 30 days. Female subjects who are pregnant, breastfeeding, were pregnant within the last three months or are planning a pregnancy during the course of the study. Active skin or deep infection at the site of implantation. History of chronic wounds or wound-healing disorders. Known connective tissue diseases (e.g. Ehlers-Danlos syndrome, Epidermolysis bullosa, Marfan syndrome, Osteogenesis imperfecta). Immune-suppressed subjects, immune-deficiency subjects (properly managed diabetes mellitus is not an exclusion criterion). 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). Known history of atrial fibrillation (in any form including paroxysmal atrial fibrillation). History of ablation for atrial fibrillation. Patients already receiving amiodarone as a treatment for atrial fibrillation or ventricular arrhythmias during the procedure. Disease of the left pleura, previous intervention in the left pleural space, or chest deformity. Subjects with end-stage chronic-renal disease / dialysis. Subjects with heart failure (BNP>1000), low ejection fraction (<35%), end stage renal disease (on dialysis or creatinine >1.8). STS risk >5.5% for 30 day mortality. Patients electing to receive an ablative procedure for atrial fibrillation.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 85 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: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, open label, single arm study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>All eligible patients that are enrolled with receive the CardiaMend patch soaked in amiodarone | Combination Product: CardiaMend with antiarrhythmic<br>* Pericardial patch with antiarrhythmic drug (amiodarone) topically applied<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of POAF | Incidence of POAF up to patient discharge as defined as atrial fibrillation/flutter (AF) after OR exit that lasted longer than one hour, or lasted less than one hour but required medical or procedural intervention. | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time until discharge | Burden of atrial fibrillation as defined by additional treatment regimen, additional time in ICU, and/or complications directly associated with atrial fibrillation. | 5 days |