RECRUITING

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

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Conditions

Atrial Fibrillation, Postoperativepost Operative Atrial FibrillationArrhythmiasCardiac Heart DiseasesCardiovascular DiseasesAtrial FibrillationAnti-Arrhythmia Agents

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-12-16
Study Completion:2026-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06730828

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:20 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subjects 20-85 years old.
  2. * Subjects able to give voluntary written informed consent, who understand and are willing to comply with study-related procedures.
  3. * Subjects scheduled to undergo open-chest cardiac surgery via complete median sternotomy.
  4. * Subjects in sinus rhythm at the time of office visit and during prior EKG (note: continuous EKG monitoring for 48 hours is not required).
  1. * 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.
  2. * Subjects with a condition that could interfere with their ability to comply with the study.
  3. * Subjects participating in an interventional clinical study or who have participated in such study during the preceding 30 days.
  4. * Female subjects who are pregnant, breastfeeding, were pregnant within the last three months, or are planning to become pregnant during the study.
  5. * Subjects with active skin or deep infection at the site of implantation.
  6. * Subjects with a history of chronic wounds or wound-healing disorders.
  7. * Subjects with known connective tissue diseases (e.g. Ehlers-Danlos syndrome, Epidermolysis bullosa, Marfan syndrome, Osteogenesis imperfecta).
  8. * Subjects who are Immune-suppressed or with immune deficiency (properly managed diabetes mellitus is not an exclusion criterion).
  9. * Subjects on concomitant oral or IV systemic corticosteroid therapy and/or other constant anti-inflammatory therapies.
  10. * 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.
  11. * Subjects with coadministration of any medications which cause QT prolongation
  12. * 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).
  13. * Subjects with a known history of atrial fibrillation or paroxysmal atrial fibrillation.
  14. * Subjects with a history of ablation for atrial fibrillation.
  15. * Subjects already receiving amiodarone as a treatment for atrial fibrillation or ventricular arrhythmias.
  16. * Subjects with a disease of the left pleura, previous intervention in the left pleural space, or chest deformity.
  17. * Subjects with heart failure (BNP\>1000), low ejection fraction (\<35%), end-stage renal disease (on dialysis or GFR\<20).
  18. * Subjects electing to receive an ablative procedure for atrial fibrillation during the index operation.
  19. * Subjects with prior cardiac surgery via sternotomy.

Contacts and Locations

Study Contact

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

Principal Investigator

Mark S. Slaughter, MD
PRINCIPAL_INVESTIGATOR
University of Louisville Hospitals

Study Locations (Sites)

University of Louisville
Louisville, Kentucky, 40202
United States

Collaborators and Investigators

Sponsor: Helios Cardio Inc.

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-16
Study Completion Date2026-05

Study Record Updates

Study Start Date2024-12-16
Study Completion Date2026-05

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Atrial Fibrillation, Postoperative