Prevention of Postoperative Atrial Fibrillation (POAF) Using Intra-Pericardial Amiodarone

EARLY_PHASE1RecruitingINTERVENTIONAL
Enrollment

63

Participants

Timeline

Start Date

February 15, 2024

Primary Completion Date

June 30, 2027

Study Completion Date

June 30, 2027

Conditions
Atrial FibrillationPost-Op Complication
Interventions
COMBINATION_PRODUCT

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."

Trial Locations (1)

60637

RECRUITING

The University of Chicago, Chicago

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Helios Cardio Inc.

INDUSTRY

lead

University of Chicago

OTHER