Amiodarone-Infused CardiaMend Patches for the Prevention of New-Onset POAF in Cardiac Surgery Subjects
Recruiting · Phase 1, Phase 2 · NCT06730828
Conditions: Atrial Fibrillation, Postoperative
At a glance
- Research payments reported, 2025
- $16,250
- U.S. investigators named
- 1
- Sites paid
- 1
- Planned or actual enrollment
- 80
About the trial
- Sponsor
- Helios Cardio Inc.
- Tested
- The intervention includes Amiodarone-Infused CardiaMend patches (70mg, 150mg and 300mg) (combination_product)
- Dates
- Started 2024-12-16; completion 2026-05
- Results posted
- Not yet
The goal of this clinical trial is to is to test the safety of a new way to deliver a commonly used drug (amiodarone) used in heart surgery by placing a patch containing the drug directly on the heart instead of in an IV (vein). Participating subjects must be 20-85 year old males or females. Up to 80 participants having cardiac surgery at the University of Louisville will be involved in this study. The main questions this study aims to answer are: 1. Is the patch safe? 2. Does the patch lower the rate of atrial fibrillation (irregular heart rhythm) after cardiac surgery? Researchers will compare up to 3 different doses of the amiodarone patches (low, medium and high) to the usual treatmen…
From ClinicalTrials.gov, last updated 2024-12-12. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Helios Cardio Inc reported $16,250 in research payments for this study in 2025 (1 payments).
Products named: Cardiamend
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.