Atrial Fibrillation, POAF
Conditions
Brief summary
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.
Interventions
COMBINATION_PRODUCTCardiaMend with antiarrhythmic
Pericardial patch with antiarrhythmic drug (amiodarone) topically applied
Sponsors
Saint Alphonsus Regional Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Prospective, open label, single arm study
Eligibility
Sex/Gender
ALL
Age
21 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of POAF | 5 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time until discharge | 5 days | Burden of atrial fibrillation as defined by additional treatment regimen, additional time in ICU, and/or complications directly associated with atrial fibrillation. |
Contacts
Primary ContactPaige Nesbitt
Backup ContactJoy Furlipa
Outcome results
None listed