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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
CardiaMend in Combination with Amiodarone
Combination productThe first three patient will receive 600 mg amiodarone into the intact pericardial space. 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. The CardiaMend patch will saturated per the instructions and be sutured into place. Amiodarone will be dripped directly over the heart.
Treatment groups
63 Participants
are divided into 2 treatment groupsGroup A: CardiaMend Pericardial and Epicardial Reconstruction Matrix used in combination with amiodaroneExperimental treatment 1 intervention
Group B: University of Chicago's standard of care in patients undergoing isolated CABG or valve surgeryNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Post Operative Atrial Fibrillation
The patients have continuous electrocardiogram (EKG) 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. Evidence of atrial fibrillation or atrial flutter will be confirmed by 12 lead electrocardiogram by loss or changes to the P wave, as well as irregularities in the QRS wave interval, heart rhythm, or rate. If clinically indicated, patients will receive a monitor for home monitoring per standard of care.
Time frame
Through discharge, an average 7 days to 2 weeksSecondary outcomes
1
Additional Hospital Time Required Due to Atrial Fibrillation/Flutter
Burden of atrial fibrillation as defined by additional treatment regimen, additional time in intensive care unit (ICU), complications directly associated with atrial fibrillation
Time frame
Through discharge, an average 7 days to 2 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Chicago
Lead sponsor
Helios Cardio Inc.
Collaborator
Source ClinicalTrials.gov