A Prospective Pilot Study of the Combination of CardiaMend and Amiodarone for the Prevention of Postoperative Atrial Fibrillation (POAF) in Patients Undergoing Isolated Coronary Artery Bypass Grafting or Isolated Valve Surgery

Saint Alphonsus Regional Medical Center0 sites30 target enrollmentJanuary 1, 2023

ConditionsPOAF Atrial Fibrillation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: POAF
Sponsor: Saint Alphonsus Regional Medical Center
Enrollment: 30
Primary Endpoint: Incidence of POAF
Status: Not yet recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The principal purpose of this investigator-initiated trial is to study the use of the CardiaMend device soaked in the anti-arrhythmic drug amiodarone, and how it may decrease the development of atrial fibrillation in patients that have undergone a coronary artery bypass surgery, or isolated valve surgery.

Registry

clinicaltrials.gov

Start Date

January 1, 2023

End Date

May 31, 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Saint Alphonsus Regional Medical Center

Responsible Party

Principal Investigator

Robert Saeid Farivar, MD

Medical Director of Cardiothoracic Surgery

Saint Alphonsus Regional Medical Center

Eligibility Criteria

Inclusion Criteria

•Aged 21-85 years
•Able to provide written informed consent, understand and be willing to comply with study-related procedures.
•Scheduled to undergo open-chest cardiac surgery via complete median sternotomy for coronary artery bypass graft (CABG), or isolated valve repair/replacement.
•Inclusionary valve repair/replacement procedures with the primary reason for surgery inclusive of aortic valve repair/replacement or mitral valve repair/replacement.
•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 consultation and on a previous EKG, or no history of atrial fibrillation (note: continuous ECG monitoring for 48 hours is not required)

Exclusion Criteria

•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 a pregnancy 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).
•The subject has an implantable cardiac device (i.e., cardiac resynchronization therapy devices with and without defibrillator capabilities (CRTs and CRT-Ds), implantable cardioverter-defibrillators (ICD) and pacemakers).
•Known history of atrial fibrillation (in any form including paroxysmal atrial fibrillation).

Outcomes

Primary Outcomes

Incidence of POAF

Time Frame: 5 days

Incidence of POAF up to patient discharge as defined as 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.