CardiaMend and Amiodarone for the Prevention of POAF

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Atrial Fibrillation; POAF
• Intervention / Treatment: Combination product: CardiaMend with antiarrhythmic

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Paige Nesbitt; Phone Number: 208-367-8386; Email: paige.nesbitt@saintalphonsus.org
• Study Contact Backup: Name: Joy Furlipa; Phone Number: 208-302-0066; Email: joy.furlipa@saintalphonsus.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).
• History of ablation for atrial fibrillation.
• Patients already receiving amiodarone as a treatment for atrial fibrillation or ventricular arrhythmias during the procedure.
• Disease of the left pleura, previous intervention in the left pleural space, or chest deformity.
• Subjects with end-stage chronic-renal disease / dialysis.
• Subjects with heart failure (BNP>1000), low ejection fraction (<35%), end stage renal disease (on dialysis or creatinine >1.8).
• STS risk >5.5% for 30 day mortality.
• Patients electing to receive an ablative procedure for atrial fibrillation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; All eligible patients that are enrolled with receive the CardiaMend patch soaked in amiodarone	Combination product: CardiaMend with antiarrhythmic; Pericardial patch with antiarrhythmic drug (amiodarone) topically applied

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of POAF	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.	5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time until discharge	Burden of atrial fibrillation as defined by additional treatment regimen, additional time in ICU, and/or complications directly associated with atrial fibrillation.	5 days

Collaborators and Investigators

• Sponsor: Saint Alphonsus Regional Medical Center
• Investigators: Principal Investigator: Robert Saeid Farivar, MD, PhD, Saint Alphonsus Regional Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): May 31, 2023
• Study Completion (Anticipated): May 31, 2023

Study Registration Dates

• First Submitted: November 21, 2022
• First Submitted That Met QC Criteria: November 29, 2022
• First Posted (Estimate): December 8, 2022

Study Record Updates

• Last Update Posted (Estimate): December 8, 2022
• Last Update Submitted That Met QC Criteria: November 29, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Anti-Arrhythmia Agents
• Other Study ID Numbers: Pro00066172

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