Amiodarone-Infused CardiaMend Patches for the Prevention of New-Onset POAF in Cardiac Surgery Subjects
Recruiting
Phase 1
Phase 2
Interventional Study
Atrial Fibrillation, Postoperative
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 20 – 85
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 80 (estimated)
- Sponsor
- Helios Cardio Inc. · Industry
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About This Trial
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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Subjects 20-85 years old.
* Subjects able to give voluntary written informed consent, who understand and are willing to comply with study-related procedures.
* Subjects scheduled to undergo open-chest cardiac surgery via complete median sternotomy.
* Subjects in sinus rhythm a…
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