CardiaMend and Amiodarone for the Prevention of POAF

NCT ID: NCT05641883

Last Updated: 2022-12-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2023-05-31

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.

Conditions

POAF; Atrial Fibrillation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Experimental

All eligible patients that are enrolled with receive the CardiaMend patch soaked in amiodarone

Group Type: EXPERIMENTAL

CardiaMend with antiarrhythmic

Intervention Type: COMBINATION_PRODUCT

Pericardial patch with antiarrhythmic drug (amiodarone) topically applied

Interventions

CardiaMend with antiarrhythmic

Pericardial patch with antiarrhythmic drug (amiodarone) topically applied

Intervention Type: COMBINATION_PRODUCT

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).
• 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Saint Alphonsus Regional Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Robert Saeid Farivar, MD

Medical Director of Cardiothoracic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert Saeid Farivar, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Saint Alphonsus Regional Medical Center

Central Contacts

Paige Nesbitt

Role: CONTACT

paige.nesbitt@saintalphonsus.org

208-367-8386

Joy Furlipa

Role: CONTACT

joy.furlipa@saintalphonsus.org

208-302-0066

Other Identifiers

Pro00066172

Identifier Type: -

Identifier Source: org_study_id