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

NCT06730828 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-12-12

No results posted yet for this 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.

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

Sponsors & Collaborators

  • Helios Cardio Inc.

    lead INDUSTRY

Principal Investigators

  • Mark S. Slaughter, MD · University of Louisville Hospitals

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-16
Primary Completion
2025-11-30
Completion
2026-05-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06730828 on ClinicalTrials.gov