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

Conditions

• Atrial Fibrillation, Postoperative

Eligibility Criteria

Sex

ALL

Age

20 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• The intervention includes Amiodarone-Infused CardiaMend patches (70mg, 150mg and 300mg) — COMBINATION_PRODUCT
  Intervention includes a topical, atrial-specific, amiodarone infused CardiaMend patch in the operating room and applied onto the epicardial surface biatrially

Study Details

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.

Key Dates

Start date

Dec 16, 2024

Status verified

Dec 2024

Primary completion

Nov 30, 2025

Completion

May 31, 2026

Study Design

Enrollment

80 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• 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

Primary Outcome Measure

Safety, defined as major adverse cardiac and cerebrovascular events (MACCE), up to subject discharge. [ Time Frame: From the day of the index procedure up to two months or date of hospital discharge, whichever is the sooner ]

Central Contacts

• Jaimin Trivedi, MBBS FACC
  502-588-7638
  [email protected]
• Chief Operating Officer, Helios Cardio Inc., PhD
  339-707-7799
  [email protected]

Locations (1)

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