RECRUITING

Prevention of Postoperative Atrial Fibrillation (POAF) Using Intra-Pericardial Amiodarone

Conditions

Atrial Fibrillation Post-Op Complication

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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 purpose of this study is to evaluate the combination of CardiaMend, with the addition of amiodarone in the prevention of postoperative atrial fibrillation (POAF) in patients undergoing cardiac arterial bypass grafting (CABG) or valve surgery.

Official Title

A Prospective Study Using Intra-Pericardial Amiodarone for the Prevention of Postoperative Atrial Fibrillation (POAF) in Patients Undergoing Cardiac Arterial Bypass Grafting and/or Valve Surgery

Quick Facts

Study Start:2024-02-15

Study Completion:2025-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06063538

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 Criteria	Exclusion Criteria
* Subject aged 20-85 years old. * Patients able to provide written informed consent, understand, and be willing to comply with study-related procedures. * Participants who are scheduled to undergo open-chest cardiac surgery via complete median sternotomy. Includes: * Coronary artery bypass graft (CABG) and/or valve repair/replacement procedures (aortic, mitral, or tricuspid) * Isolated ascending aortic aneurysm replacement/repair * Note: Left atrial appendage (LAA) procedures are allowed if CABG and/or valve repair or replacement is the qualifying surgical procedure, but is not a qualifying surgical procedure on its own. * In sinus rhythm at the time of office visit and prior electrocardiogram (EKG) (note: continuous EKG monitoring for 48 hours is not required).	* Subject unable to give voluntary written informed consent, is unlikely to cooperate or is legally incompetent, including subjects who are institutionalized by court or official order, or in a dependency relationship with, testing center or investigator. * Any condition which could interfere with the subject's ability to comply with the study. * Ongoing participation in an interventional clinical study or 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 course of the study. * Active skin or deep infection at the site of implantation. * History of chronic wounds or wound-healing disorders. * Known connective tissue diseases (e.g. Ehlers-Danlos syndrome, Epidermolysis bullosa, Marfan syndrome, Osteogenesis imperfecta). * Immune-suppressed subjects, immune-deficiency subjects (properly managed diabetes mellitus is not an exclusion criterion). * Concomitant oral or IV systemic corticosteroid therapy and/or other constant anti-inflammatory therapies. * Patients already receiving amiodarone as a treatment for atrial fibrillation or ventricular arrhythmias. * Disease of the left pleura, previous intervention in the left pleural space, or chest deformity. * Subjects with end-stage chronic-renal disease / dialysis. * STS (Society of Thoracic Surgeons Score) risk score \>5.5% for 30 day mortality.

Inclusion Criteria

Exclusion Criteria

* Subject aged 20-85 years old.
* Patients able to provide written informed consent, understand, and be willing to comply with study-related procedures.
* Participants who are scheduled to undergo open-chest cardiac surgery via complete median sternotomy. Includes:
* Coronary artery bypass graft (CABG) and/or valve repair/replacement procedures (aortic, mitral, or tricuspid)
* Isolated ascending aortic aneurysm replacement/repair
* Note: Left atrial appendage (LAA) procedures are allowed if CABG and/or valve repair or replacement is the qualifying surgical procedure, but is not a qualifying surgical procedure on its own.
* In sinus rhythm at the time of office visit and prior electrocardiogram (EKG) (note: continuous EKG monitoring for 48 hours is not required).

* Subject unable to give voluntary written informed consent, is unlikely to cooperate or is legally incompetent, including subjects who are institutionalized by court or official order, or in a dependency relationship with, testing center or investigator.
* Any condition which could interfere with the subject's ability to comply with the study.
* Ongoing participation in an interventional clinical study or 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 course of the study.
* Active skin or deep infection at the site of implantation.
* History of chronic wounds or wound-healing disorders.
* Known connective tissue diseases (e.g. Ehlers-Danlos syndrome, Epidermolysis bullosa, Marfan syndrome, Osteogenesis imperfecta).
* Immune-suppressed subjects, immune-deficiency subjects (properly managed diabetes mellitus is not an exclusion criterion).
* Concomitant oral or IV systemic corticosteroid therapy and/or other constant anti-inflammatory therapies.
* Patients already receiving amiodarone as a treatment for atrial fibrillation or ventricular arrhythmias.
* Disease of the left pleura, previous intervention in the left pleural space, or chest deformity.
* Subjects with end-stage chronic-renal disease / dialysis.
* STS (Society of Thoracic Surgeons Score) risk score \>5.5% for 30 day mortality.

Contacts and Locations

Study Contact

Kayla Moore, BS

CONTACT

773-702-8228

kaymoore@bsd.uchicago.edu

Valluvan Jeevanandam, MD

CONTACT

773-702-2500

jeevan@bsd.uchicago.edu

Principal Investigator

Valluvan Jeevanandam, MD

PRINCIPAL_INVESTIGATOR

Director of Heart and Vascular Center

Study Locations (Sites)

The University of Chicago

Chicago, Illinois, 60637

United States

Collaborators and Investigators

Sponsor: University of Chicago

Valluvan Jeevanandam, MD, PRINCIPAL_INVESTIGATOR, Director of Heart and Vascular Center

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 Date2024-02-15

Study Completion Date2025-06

Study Record Updates

Study Start Date2024-02-15

Study Completion Date2025-06

Terms related to this study

Additional Relevant MeSH Terms

Atrial Fibrillation
Post-Op Complication