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

NCT06730828 | Recruiting Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: CP001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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:

• 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

Keywords

post Operative Atrial Fibrillation; Arrhythmias; Cardiac Heart Diseases; Cardiovascular Diseases; Atrial Fibrillation; Anti-Arrhythmia Agents

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Incidence of postoperative atrial fibrillation (POAF)

  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.

  One day before the date of hospital discharge up to two months

• Length of Stay.

  From the day of the index procedure to hospital discharge up to 2 months

• Hospital readmission.

  Up to 30 days post-subject hospital discharge.

• POAF duration

  From the day of the index procedure up to two months or date of hospital discharge, whichever is the sooner

Study Arms (4)

Group 1: 20 subjects in the control group, which is the standard of care (i.e., no CardiaMend-Amioda

NO INTERVENTION

Subjects in treatment Group 1 (control) will receive no CardiaMend-Amiodarone patches.

Group 2: 20 subjects receiving CardiaMend-Amiodarone infused with 70 mg of amiodarone

EXPERIMENTAL

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)

Group 3: 20 subjects receiving CardiaMend-Amiodarone infused with 150 mg of amiodarone.

EXPERIMENTAL

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)

Group 4: 20 subjects receiving CardiaMend-Amiodarone infused with 300 mg of amiodarone.

EXPERIMENTAL

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)

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

Group 2: 20 subjects receiving CardiaMend-Amiodarone infused with 70 mg of amiodarone; Group 3: 20 subjects receiving CardiaMend-Amiodarone infused with 150 mg of amiodarone.; Group 4: 20 subjects receiving CardiaMend-Amiodarone infused with 300 mg of amiodarone.

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Helios Cardio Inc.: lead

Study Sites (1)

University of Louisville

Louisville, Kentucky, 40202, United States

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mark S. Slaughter, MD

  University of Louisville Hospitals

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jaimin Trivedi, MBBS FACC

CONTACT

502-588-7638; jaimin.trivedi@louisville.edu

Chief Operating Officer, Helios Cardio Inc., PhD

CONTACT

339-707-7799; pjackson@helioscardio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects undergoing cardiac surgery via complete median sternotomy

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 12, 2024
• Study Start: December 16, 2024
• Primary Completion: November 1, 2025
• Study Completion: May 1, 2026
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)