Prevention of Postoperative Atrial Fibrillation (POAF) Using Intra-Pericardial Amiodarone
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age20-85
SponsorUniversity of Chicago
About this trial
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.
Eligibility criteria
Qualifiers
Subject aged 20-85 years old.
Patients able to provide written informed consent, understand, and be willing to comply with study-related procedures.
Coronary artery bypass graft (CABG) and/or valve repair/replacement procedures (aortic, mitral, or tricuspid)
Isolated ascending aortic aneurysm replacement/repair
Disqualifiers
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.
Trial design
Treatments tested in this trial
- CardiaMend in Combination with Amiodarone
Treatment groups
63 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Chicago
Lead sponsor
Helios Cardio Inc.
Collaborator
Source ClinicalTrials.gov