A Prospective Study Using Intra-Pericardial Amiodarone for the Prevention of Postoperative Atrial Fibrillation (POAF) in Patients Undergoing Cardiac Arterial Bypass Grafting and/or Valve Surgery

IRB23-0847

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 cardiac arterial bypass grafting (CABG) or valve surgery.

2024-02-15

2024-11-01

2025-06-01

Recruiting

Early phase I

63

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) and/or valve repair/replacement procedures (aortic, mitral, or tricuspid) * Isolated ascending aortic aneurysm replacement/repair * 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 electrocardiogram (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. * 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. * STS (Society of Thoracic Surgeons Score) risk score \>5.5% for 30 day mortality.

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'To demonstrate that there is no systemic presence of amiodarone, the first three patient will receive 600 mg amiodarone into the intact pericardial space (IPS). Amiodarone serum levels will be tested at post operative days 2 and 6. The study will only proceed if there is a serum amiodarone level less than 25% of the normal therapeutic level. This should insure lack of systemic toxicity. After the first 3 patients have demonstrated low amiodarone blood levels, a total of up to 60 patients will be enrolled in the study.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 63, 'type': 'ESTIMATED'}}

2024-04-17