63
Participants
Start Date
February 15, 2024
Primary Completion Date
June 30, 2027
Study Completion Date
June 30, 2027
CardiaMend in Combination with Amiodarone
"The 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."
RECRUITING
The University of Chicago, Chicago
Collaborators (1)
Helios Cardio Inc.
INDUSTRY
University of Chicago
OTHER