CardiaMend and Amiodarone for the Prevention of POAF

Launched by SAINT ALPHONSUS REGIONAL MEDICAL CENTER · Nov 29, 2022

Keywords

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Gender

ALL

Eligibility criteria

• 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.

Trial Officials