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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation, Postoperative
• Intervention / Treatment: Combination product: The intervention includes Amiodarone-Infused CardiaMend patches (70mg, 150mg and 300mg)

Detailed Description

The purpose of this study is to determine the safety of a drug-device treatment for the prevention of postoperative atrial fibrillation following open heart surgery. Approximately a quarter of patients will develop atrial fibrillation after open heart surgery. Atrial fibrillation is a type of irregular heart rhythm or arrhythmia, in which the heart does not pump effectively. This can lead to problems such as stroke, palpitations (an abnormal heart rhythm that can feel like your heart is racing or pounding) and prolonged hospital stays. The goal of this study is to determine if the application of a medication (amiodarone) containing patch on the surface of the heart at the time of surgery is safe, which may lead to a treatment to lower the rate of atrial fibrillation in patients undergoing open heart surgery. The study drug-device is not yet FDA approved.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Jaimin Trivedi, MBBS FACC; Phone Number: 502-588-7638; Email: jaimin.trivedi@louisville.edu
• Study Contact Backup: Name: Chief Operating Officer, Helios Cardio Inc., PhD; Phone Number: 339-707-7799; Email: pjackson@helioscardio.com

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Recruiting
      • University of Louisville
      • Contact: Jaimin Trivedi, MD FACC; Phone Number: 708-606-3115; Email: jaimin.trivedi@louisville.edu
      • Contact: Terry Blanton, BSN RN; Phone Number: 502-587-4381; Email: mary.blanton@louisville.edu
      • Contact: Mark Slaughter, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Exclusion Criteria:

• Subjects unable to give voluntary written informed consent, unlikely to cooperate, or legally incompetent, including subjects institutionalized by court or official order, or in a dependency relationship with testing center or investigator.
• Subjects with a condition that could interfere with their ability to comply with the study.
• Subjects participating in an interventional clinical study or who have participated in such study during the preceding 30 days.
• Female subjects who are pregnant, breastfeeding, were pregnant within the last three months, or are planning to become pregnant during the study.
• Subjects with active skin or deep infection at the site of implantation.
• Subjects with a history of chronic wounds or wound-healing disorders.
• Subjects with known connective tissue diseases (e.g. Ehlers-Danlos syndrome, Epidermolysis bullosa, Marfan syndrome, Osteogenesis imperfecta).
• Subjects who are Immune-suppressed or with immune deficiency (properly managed diabetes mellitus is not an exclusion criterion).
• Subjects on concomitant oral or IV systemic corticosteroid therapy and/or other constant anti-inflammatory therapies.
• Subjects on the following medications with known interactions with amiodarone: doxorubicin, fosphenytoin, lopinavir-ritonavir, ledipasvir/sofosbuvir, quinidine , procainamide, disopyramide, other Vaughan William class III agents including dofetilide, dronedarone, ibutilide and vernakalant.
• Subjects with coadministration of any medications which cause QT prolongation
• Subjects with implantable cardiac devices (i.e., cardiac resynchronization therapy devices with and without defibrillator capabilities (CRTs and CRT-Ds), implantable cardioverter-defibrillators (ICD), and pacemakers).
• Subjects with a known history of atrial fibrillation or paroxysmal atrial fibrillation.
• Subjects with a history of ablation for atrial fibrillation.
• Subjects already receiving amiodarone as a treatment for atrial fibrillation or ventricular arrhythmias.
• Subjects with a disease of the left pleura, previous intervention in the left pleural space, or chest deformity.
• Subjects with heart failure (BNP>1000), low ejection fraction (<35%), end-stage renal disease (on dialysis or GFR<20).
• Subjects electing to receive an ablative procedure for atrial fibrillation during the index operation.
• Subjects with prior cardiac surgery via sternotomy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	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
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	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
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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety, defined as major adverse cardiac and cerebrovascular events (MACCE), up to subject discharge.	MACCE is defined as in-hospital all-cause death, acute myocardial infarction (AMI), or ischemic stroke.	From the day of the index procedure up to two months or date of hospital discharge, whichever is the sooner

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of postoperative atrial fibrillation (POAF)	Incidence of POAF up to patient discharge; defined as subject experiencing atrial fibrillation/flutter (AF) after OR Exit that lasted longer than one hour, or lasted less than one hour but required medical or procedural intervention.	From the day of the index procedure up to two months or date of hospital discharge, whichever is the sooner
Migration of cardiamend-amiodarone patches.	Confirm placement of patches with non-contrast thoracic CT scan on first 3 subjects from Group 2 (70 mg) prior to discharge.	One day before the date of hospital discharge up to two months
Length of Stay.	Length of initial hospital stay.	From the day of the index procedure to hospital discharge up to 2 months
Hospital readmission.	30 day readmission from discharge due to all cause complications based upon STS data	Up to 30 days post-subject hospital discharge.
POAF duration	Duration of POAF, if observed.	From the day of the index procedure up to two months or date of hospital discharge, whichever is the sooner
Discharge on antiarrhythmic drug.	Discharge on antiarrhythmic drug, if POAF observed.	At subject hospital discharge to a maximum of 2 months post-index procedure date.
Discharge on oral anticoagulation.	Discharge on oral anticoagulation, if POAF observed.	At subject hospital discharge to a maximum of 2 months post-index procedure date.

Collaborators and Investigators

• Sponsor: Helios Cardio Inc.
• Investigators: Principal Investigator: Mark S. Slaughter, MD, University of Louisville Hospitals

Study record dates

Study Major Dates

• Study Start (Estimated): December 16, 2024
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: December 3, 2024
• First Submitted That Met QC Criteria: December 11, 2024
• First Posted (Estimated): December 12, 2024

Study Record Updates

• Last Update Posted (Estimated): December 12, 2024
• Last Update Submitted That Met QC Criteria: December 11, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Cardiovascular Diseases; Arrhythmias; Anti-Arrhythmia Agents; post Operative Atrial Fibrillation; Cardiac Heart Diseases
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Arrhythmia Agents; Sodium Channel Blockers; Membrane Transport Modulators; Cytochrome P-450 Enzyme Inhibitors; Vasodilator Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 CYP2D6 Inhibitors; Potassium Channel Blockers; Cytochrome P-450 CYP1A2 Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Amiodarone
• Other Study ID Numbers: CP001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No