CardiaMend and Amiodarone for the Prevention of POAF

NCT05641883 | Unknown FDA Device

• 1 other identifier: Pro00066172
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Time until discharge

  5 days

Study Arms (1)

Experimental

EXPERIMENTAL

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

Combination Product: CardiaMend with antiarrhythmic

Interventions

CardiaMend with antiarrhythmic COMBINATION_PRODUCT

Pericardial patch with antiarrhythmic drug (amiodarone) topically applied

Experimental

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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)

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Saint Alphonsus Regional Medical Center: lead

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Anti-Arrhythmia Agents

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Robert Saeid Farivar, MD, PhD

  Saint Alphonsus Regional Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paige Nesbitt

CONTACT

208-367-8386; paige.nesbitt@saintalphonsus.org

Joy Furlipa

CONTACT

208-302-0066; joy.furlipa@saintalphonsus.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director of Cardiothoracic Surgery

Model Details: Prospective, open label, single arm study

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: December 8, 2022
• Study Start: January 1, 2023
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: December 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share