Use of Amiodarone-Infused CardiaMend (CardiaMend-Amiodarone) Patches for the Prevention of New-Onset Postoperative Atrial Fibrillation (POAF) in Subjects Undergoing Cardiac Surgery

Status: Recruiting
Location: See location...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 85
Healthy Volunteers: f
View:

• 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 at the time of office visit and during prior EKG (note: continuous EKG monitoring for 48 hours is not required).

Locations
United States
Kentucky
University of Louisville
RECRUITING
Louisville
Contact Information
Primary
Jaimin Trivedi, MBBS FACC
jaimin.trivedi@louisville.edu
502-588-7638
Backup
Chief Operating Officer, Helios Cardio Inc., PhD
pjackson@helioscardio.com
339-707-7799
Time Frame
Start Date: 2024-12-16
Estimated Completion Date: 2026-05
Participants
Target number of participants: 80
Treatments
No_intervention: Group 1: 20 subjects in the control group, which is the standard of care (i.e., no CardiaMend-Amioda
Subjects in treatment Group 1 (control) will receive no CardiaMend-Amiodarone patches.
Experimental: Group 2: 20 subjects receiving CardiaMend-Amiodarone infused with 70 mg of amiodarone
Subjects in Group 2 (70 mg) will receive three patches each as follows:~* One patch (5x6 cm) will be placed on top of the right atrium;~* One patch (3x5 cm) will be placed within the transverse sinus near the dome of the left atrium; and~* One patch (3x5 cm) will be placed within the oblique sinus on the posterior/inferior aspect of left atrium
Experimental: Group 3: 20 subjects receiving CardiaMend-Amiodarone infused with 150 mg of amiodarone.
Subjects in Group 3 (150 mg) will receive three patches each as follows:~* One patch (5x6 cm) will be placed on top of the right atrium;~* One patch (3x5 cm) will be placed within the transverse sinus near the dome of the left atrium; and~* One patch (3x5 cm) will be placed within the oblique sinus on the posterior/inferior aspect of left atrium
Experimental: Group 4: 20 subjects receiving CardiaMend-Amiodarone infused with 300 mg of amiodarone.
Subjects in Group 4 (300 mg) will receive three patches each as follows:~* One patch (5x6 cm) will be placed on top of the right atrium;~* One patch (3x5 cm) will be placed within the transverse sinus near the dome of the left atrium; and~* One patch (3x5 cm) will be placed within the oblique sinus on the posterior/inferior aspect of left atrium
Related Therapeutic Areas
Sponsors
Leads: Helios Cardio Inc.

This content was sourced from clinicaltrials.gov

Similar Clinical Trials