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NCT06730828 · ClinicalTrials.gov registry record · Phase 1
Amiodarone-Infused CardiaMend Patches for the Prevention of New-Onset POAF in Cardiac Surgery Subjects
A Phase 1 study of Atrial Fibrillation, Postoperative, sponsored by Helios Cardio.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT06730828: Recruiting Phase 1 study of Atrial Fibrillation, Postoperative, sponsored by Helios Cardio.
NCT06730828 is a Phase 1 study of Atrial Fibrillation, Postoperative that is actively recruiting participants, run by Helios Cardio. The registered enrollment target is 80 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06730828, a Phase 1 study of Atrial Fibrillation, Postoperative, is actively recruiting participants, sponsored by Helios Cardio.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
Study Summary
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 treatment (Standard of Care) to see if there are differences (increases or decreases) in heart rhythms after cardiac surgery across study groups. Participants will be placed in one of 4 study groups: * Standard of Care (20 participants) * Low dose patch (20 participants) * Medium dose patch (20 participants) * High dose patch (20 participants) Participants will be monitored closely by their doctor(s) during the study and would: * Agree to participate after having their doctor, or a member of the team, explain the study in detail and allowing them to ask any questions they would like. * Sign an Informed Consent Form which will describe the study and tests in full. * Agree to have their doctor and his/her research team record your medical information, draw blood, and perform electrocardiograms, or EKGs (quick, painless test that measures the electrical activity of the heart) and echocardiograms (image of heart) to monitor their heart. * Agree to receive training on the portable EKG recorder and to use it at home approximately 30 days and 6 months after their surgery to monitor their heart. * Agree to return to the hospital approximately 30 days and 6 months after their surgery for a study visit. Participant involvement will be approximately 7 months total.
Primary Outcome
MACCE is defined as in-hospital all-cause death, acute myocardial infarction (AMI), or ischemic stroke.
Conditions Studied
Interventions
- COMBINATION_PRODUCT The intervention includes Amiodarone-Infused CardiaMend patches (70mg, 150mg and 300mg)
Study Locations (1)
Kentucky
- University of Louisville - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2024-12-16 |
| Est. Completion | 2026-05 |
| Phase | Phase 1 |
What NCT06730828 shows while recruiting
NCT06730828 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% higher).
The record links to 1 condition, with Atrial Fibrillation, Postoperative appearing as the primary indexed condition, and to 1 intervention - of which The intervention includes Amiodarone-Infused CardiaMend patches (70mg, 150mg and 300mg) is the first listed.
NCT06730828 reports a single indexed study location in Kentucky.
Frequently Asked Questions
What is clinical trial NCT06730828 about?
NCT06730828 is a clinical study titled "Amiodarone-Infused CardiaMend Patches for the Prevention of New-Onset POAF in Cardiac Surgery Subjects". 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 8...
What is the current status of trial NCT06730828?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2024-12-16. Estimated completion is 2026-05.
What conditions does trial NCT06730828 study?
This clinical trial studies the following conditions: Atrial Fibrillation, Postoperative.
What interventions are being tested in trial NCT06730828?
The interventions under investigation include: The intervention includes Amiodarone-Infused CardiaMend patches (70mg, 150mg and 300mg) (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT06730828?
This trial is sponsored by Helios Cardio, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06730828 being conducted?
This trial has 1 study location across Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06730828's enrollment target sits among peer trials
80 672nd of 2000 higher than 1,305 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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