Clinical trial NCT05641883: CardiaMend and Amiodarone for the Prevention of POAF
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: POAF
Atrial Fibrillation
Lead sponsor: Saint Alphonsus Regional Medical Center
Sponsor class: OTHER
First posted: 2022-12-08
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, open label, single arm study
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Incidence of POAF
timeFrame: 5 days
Secondary outcomes:
measure: Time until discharge
timeFrame: 5 days
Other outcomes:
Locations:
Study officials:
affiliation: Saint Alphonsus Regional Medical Center
name: Robert Saeid Farivar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: