Amiodarone-Infused CardiaMend Patches for the Prevention of New-Onset POAF in Cardiac Surgery Subjects

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

December 16, 2024

Primary Completion Date

November 30, 2025

Study Completion Date

May 31, 2026

Conditions
Atrial Fibrillation, Postoperative
Interventions
COMBINATION_PRODUCT

The intervention includes Amiodarone-Infused CardiaMend patches (70mg, 150mg and 300mg)

Intervention includes a topical, atrial-specific, amiodarone infused CardiaMend patch in the operating room and applied onto the epicardial surface biatrially

Trial Locations (1)

40202

RECRUITING

University of Louisville, Louisville

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Helios Cardio Inc.

INDUSTRY