Prevention of Post-OP AFib Using Combination of CardiaMend and Amiodarone

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the combination of CardiaMend, with the addition of amiodarone in the prevention of postoperative atrial fibrillation (POAF) in patients undergoing isolated cardiac arterial bypass grafting (CABG) or valve surgery.

Detailed Description
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This study will investigate CardiaMend, an FDA cleared (K210331) pericardial reconstruction matrix used in combination with amiodarone, an FDA approved antiarrhythmic drug, as a prevention of POAF. This is a single-center, prospective, pilot study, enrolling adult subjects undergoing isolated cardiac arterial bypass surgery or isolated valve surgery, via complete median sternotomy. CardiaMend should be used according to the Instructions for Use with the exception that device hydration is performed with 3 ampules of amiodarone (150mg/3ml) instead of room temperature saline. For best results, the device should be fixed in place using a continuous or interrupted stitch (approximately 1 stitch per cm) to approximate the edge of the pericardial defect. The closed defect should not put pressure on the underlying structures. A non-absorbable monofilament suture is preferred such as 5-0 or 4-0 prolene. A small edge may be left open for drain placement and a small slit for LIMA in case of CABG. Patients will have continuous EKG until discharge. If clinically indicated, patients will receive a monitor for home monitoring per standard of care.

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 Cardiac Arterial Bypass Grafting or Isolated Valve Surgery (CAMP POAF)

Conditions
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Post Operative Atrial Fibrillation

Intervention / Treatment
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* Combination Product: CardiaMend with the Addition of Amiodarone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject aged 20-85 years old. Patients able to provide written informed consent, understand, and be willing to comply with study-related procedures. Participants who are scheduled to undergo open-chest cardiac surgery via complete median sternotomy. Includes: Coronary artery bypass graft (CABG) or valve repair/replacement, or Inclusionary valve repair/replacement procedures for the primary reason for surgery include: aortic valve repair/replacement, mitral valve repair/replacement. Note: 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 office visit and prior EKG (note: continuous EKG monitoring for 48 hours is not required). Exclusion Criteria: Subject 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 to become pregnant 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). Concomitant oral or IV systemic corticosteroid therapy and/or other constant anti-inflammatory therapies. 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 or paroxysmal atrial fibrillation. History of ablation for atrial fibrillation. Patients already receiving amiodarone as a treatment for atrial fibrillation or ventricular arrhythmias. 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 during the index operation.

Ages Eligible for Study
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Minimum Age: 20 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: Patients undergoing isolated cardiac arterial bypass surgery or isolated valve surgery, via complete median sternotomy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single Arm<br>All patients who are enrolled into the study will receive the treatment. This includes the CardiaMend which should be used according to the Instructions for Use with the exception that device hydration is performed with 3 ampules of amiodarone (150mg/3ml) instead of room temperature saline. For best results, the device should be fixed in place using a continuous or interrupted stitch (approximately 1 stitch per cm) to approximate the edge of the pericardial defect. The closed defect should not put pressure on the underlying structures. A non-absorbable monofilament suture is preferred such as 5-0 or 4-0 prolene. A small edge may be left open for drain placement and a small slit for LIMA in case of CABG | Combination Product: CardiaMend with the Addition of Amiodarone<br>* The CardiaMend patch will be saturated with Amiodarone prior to being sutured into place.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post Operative Atrial Fibrillation | The patient have continuous ECG monitoring until discharge to evaluate for any evidence of atrial fibrillation or atrial flutter which lasts longer than one hour or if less than one hour, requires medical or procedural intervention | Through discharge, an average of 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Additional Hospital Time Required Due to Atrial Fibrillation/Flutter | Burden of atrial fibrillation as defined by additional treatment regimen, additional time in ICU, complications directly associated with atrial fibrillation | Through discharge, an average of 2 weeks |