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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | All eligible patients that are enrolled with receive the CardiaMend patch soaked in amiodarone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CardiaMend with antiarrhythmic | Combination Product | Pericardial patch with antiarrhythmic drug (amiodarone) topically applied |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paige Nesbitt | Contact | 208-367-8386 | paige.nesbitt@saintalphonsus.org | |
| Joy Furlipa | Contact | 208-302-0066 | joy.furlipa@saintalphonsus.org |
| Name | Affiliation | Role |
|---|---|---|
| Robert Saeid Farivar, MD, PhD | Saint Alphonsus Regional Medical Center | Principal Investigator |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000889 | Anti-Arrhythmia Agents |
| ID | Term |
|---|---|
| D002317 | Cardiovascular Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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Prospective, open label, single arm study
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| D013568 |
| Pathological Conditions, Signs and Symptoms |