Intra-Pericardial Amiodarone for Postoperative Atrial Fibrillation
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase < 1
Recruiting
Sponsor: University of Chicago
Must be taking: CardiaMend, Amiodarone
Must not be taking: Corticosteroids, Anti-inflammatories
Disqualifiers: Pregnancy, Connective tissue diseases, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?The purpose of this study is to evaluate the combination of CardiaMend, with the addition of amiodarone in the prevention of postoperative atrial fibrillation (POAF) in patients undergoing cardiac arterial bypass grafting (CABG) or valve surgery.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are already taking amiodarone or certain anti-inflammatory therapies.
What data supports the effectiveness of the drug Intra-Pericardial Amiodarone for preventing postoperative atrial fibrillation?
Research suggests that amiodarone, when used as part of a prevention plan, may reduce the occurrence of atrial fibrillation (a type of irregular heartbeat) after surgery and shorten hospital stays. Intrapericardial amiodarone, specifically, is considered potentially effective in preventing this condition, although more studies are needed to confirm its benefits.
12345Is intra-pericardial amiodarone safe for humans?
Amiodarone, including formulations like Nexterone, has been shown to be generally safe in humans for treating heart rhythm problems, though it can have side effects like low blood pressure. It has been used safely in patients with heart conditions like heart attacks and heart failure, but its safety specifically for intra-pericardial use is not detailed in the available studies.
678910How is intrapericardial amiodarone different from other drugs for postoperative atrial fibrillation?
Intrapericardial amiodarone is unique because it is administered directly into the pericardium (the sac surrounding the heart), which may help prevent postoperative atrial fibrillation while minimizing the systemic side effects typically associated with oral or intravenous amiodarone.
123511Eligibility Criteria
This trial is for adults aged 20-85 undergoing open-chest heart surgery, such as bypass or valve repair, who can consent and follow study procedures. Excluded are those with certain conditions that affect compliance, ongoing clinical study participation, pregnancy/breastfeeding recently or during the study, infections at implant sites, connective tissue diseases, immune deficiencies (except well-managed diabetes), high surgical risk scores (>5.5%), chronic wounds or on amiodarone already.Inclusion Criteria
I am scheduled for open-chest heart surgery, including procedures like bypass or valve repair.
I am between 20 and 85 years old.
Your heart is beating regularly when you visit the doctor and during your previous electrocardiogram (EKG) test.
+1 more
Exclusion Criteria
I am currently taking amiodarone for heart rhythm problems.
I am not pregnant, breastfeeding, have been pregnant in the last 3 months, nor plan to become pregnant during the study.
I have an infection where my implant will be placed.
+10 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
CardiaMend and amiodarone are used during cardiac surgery to prevent postoperative atrial fibrillation
Surgery duration
1 visit (in-person, surgery)
Monitoring
Continuous electrocardiogram (EKG) monitoring until discharge to evaluate for atrial fibrillation
7 days to 2 weeks
Continuous monitoring (in-hospital)
Follow-up
Participants are monitored for safety and effectiveness after discharge, including home monitoring if clinically indicated
4 weeks
Participant Groups
The trial tests a combination of CardiaMend with Amiodarone to prevent postoperative atrial fibrillation in patients after cardiac surgery like artery bypass grafting or valve surgery. It aims to see if this combo is more effective than current methods used.
2Treatment groups
Experimental Treatment
Active Control
Group I: CardiaMend Pericardial and Epicardial Reconstruction Matrix used in combination with amiodaroneExperimental Treatment1 Intervention
Patients randomized to this study arm includes the CardiaMend which will be used according to the instructions for use. It will be patted dry to facilitate implantation. Pieces will be cut to cover the right and left atria. The remaining piece will be contoured to close the anterior pericardial space. Four ampules of amiodarone (150mg/3ml; 12cc total volume) will be drawn into a syringe. 2cc will be dripped over the right atrium and a small CardiaMend patch placed to cover this area. Another 2cc will be used over the left atrium and covered with the CardiaMend. The anterior pericardial space will be closed without putting pressure on the underlying structures using the CardiaMend attached to the native pericardium utilizing running 4-0 monofilament suture.
Group II: University of Chicago's standard of care in patients undergoing isolated CABG or valve surgeryActive Control1 Intervention
The standard of care for this study at The University of Chicago is to ligate the left atrial appendage (LAA) during the proposed cardiac surgery (intra-operative) to reduce the occurrence of post operative atrial fibrillation (A-FIB) in combination with amiodarone injections (if applicable).
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The University of ChicagoChicago, IL
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Who Is Running the Clinical Trial?
University of ChicagoLead Sponsor
Helios Cardio IncCollaborator
Helios Cardio Inc.Industry Sponsor
References
Simple amiodarone protocol reduces postoperative atrial fibrillation. [2012]: Incorporating amiodarone into an existing postoperative atrial fibrillation (AF) prevention pathway may reduce postoperative AF and length of stay (LOS).
The effect of amiodarone on cardiac rhythm after cardiopulmonary bypass in patients with atrial fibrillation. [2022]The intraoperative use of amiodarone in patients with atrial fibrillation (AF) undergoing valvular heart surgery was unclear. Hence, a randomized clinical trial was designed to evaluate the effect of amiodarone on cardiac recovery and rhythm following mitral valve surgery.
Intrapericardial Amiodarone for the Prevention of Postoperative Atrial Fibrillation. [2016]Despite probably being the most effective prophylactic drug for postoperative atrial fibrillation (POAF), amiodarone is reserved as a second-line agent because of its potential systemic side effects. Herein, we review the available experimental and clinical trials examining the effectiveness of intrapericardial (IPC) amiodarone administration in preventing POAF which, if confirmed by future studies, can have a significant impact on cardiac surgery practice.
Intravenous amiodarone for the prevention of atrial fibrillation after open heart surgery: the Amiodarone Reduction in Coronary Heart (ARCH) trial. [2019]This study was designed to test whether intravenous (i.v.) amiodarone would prevent atrial fibrillation and decrease hospital stay after open heart surgery.
Perioperative intravenous amiodarone does not reduce the burden of atrial fibrillation in patients undergoing cardiac valvular surgery. [2013]Atrial fibrillation is a common complication after cardiac surgery. Postoperative atrial fibrillation is associated with increased risks of morbidity and mortality, and, therefore, preventive strategies using oral amiodarone have been developed but are often unpractical. Intravenous amiodarone administered after the induction of anesthesia and continued postoperatively for 48 h could represent an effective strategy to prevent postoperative atrial fibrillation in patients undergoing cardiac valvular surgery.
Amiodarone (Nexterone) injection for the treatment and prophylaxis of frequently recurring ventricular fibrillation. [2013]Intravenous (IV) amiodarone is the most used and effective drug to manage life-threatening ventricular arrhythmias. However, its administration is associated with important adverse effects, the most frequent of which is hypotension. Nexterone® is a novel IV amiodarone formulation, proved to be devoid of hypotensive effects in clinical studies and may represent an improved and safer instrument in this setting.
[Efficacy of amiodarone versus propafenone in the prevention of rhythm disorders in patients after aortocoronary bypass surgery]. [2013]A prospective randomized study was conducted to compare the antiarrhythmic activity of amiodarone and propafenone used to prevent atrial fibrillation (AF) after aortocoronary bypass surgery (ACBS). The study included 100 patients who had undergone myocardial revascularization. The patients were divided into 2 groups that did not significantly differ in their baseline condition, history data, the type of a surgical intervention, and the incidence of postoperative complications. Antiarrhythmic therapy was initiated within the first 24 hours after surgery. Group 1 (n=50) was given intravenous amiodarone in a dose of 6 mg/kg/day. Rhythm disturbances occurred in 13 (26%) patients. Group 2 (n=50) received oral propaferone in a dose of 6.6 mg/kg/day. AF occurred in 5 (10%) patients. The difference between Groups 1 and 2 was statistically significant (p = 0.047). The preventive use of propafenone recovered sinus rhythm in earlier periods (4602 +/- 71 min) than that of amiodarone (760 +/- 82 min); p = 0.049. Thus, propafenone was found to be a more effective drug used to prevent AF after ACBS, which is attributable to different pharmacodynamic behavior of the agents.
Amiodarone: clinical trials. [2022]Amiodarone is an antiarrhythmic agent commonly used in the treatment of supraventricular and ventricular tachyarrhythmias. This article reviews the results and clinical implications of primary and secondary prevention trials in which amiodarone was used in one of the treatment arms. Key post-myocardial infarction primary prevention trials include the European Myocardial Infarct Amiodarone Trial (EMIAT) and the Canadian Amiodarone Myocardial Infarction Trial (CAMIAT), both of which demonstrated that amiodarone reduced arrhythmic but not overall mortality. In congestive heart failure patients, amiodarone was studied as a primary prevention strategy in two pivotal trials: Grupo de Estudio de la Sobrevida en la Insuficiencia Cardiac en Argentina (GESICA) and Amiodarone in Patients With Congestive Heart Failure and Asymptomatic Ventricular Arrhythmia (CHF-STAT). Amiodarone was associated with a neutral overall survival and a trend toward improved survival in nonischemic cardiomyopathy patients in CHF/STAT and improved survival in GESICA. In post-myocardial infarction patients with nonsustained ventricular tachycardia and a depressed ejection fraction, the Multicenter Automatic Defibrillator Implantation Trial (MADIT) demonstrated that implantable cardioverter-defibrillators (ICD) statistically improved survival compared to the antiarrhythmic drug arm, most of whose patients were taking amiodarone. In patients with histories of sustained ventricular tachycardia or ventricular fibrillation, the Cardiac Arrest Study in Seattle: Conventional Versus Amiodarone Drug Evaluation (CASCADE) trial demonstrated that empiric amiodarone lowered arrhythmic recurrence rates compared to other drugs guided by serial Holter or electrophysiologic studies. However, arrhythmic death rates were high in both treatment arms of the study. Several secondary prevention trials, including the Antiarrhythmics Versus Implantable Defibrillators Study (AVID), the Canadian Implantable Defibrillator Study (CIDS), and the Cardiac Arrest Study Hamburg (CASH), have demonstrated the superiority of ICD therapy compared to empiric amiodarone in improving overall survival. Based on the above findings, amiodarone is safe to use in post-myocardial infarction and congestive heart failure patients that need antiarrhythmic therapy. Although amiodarone is effective in treating malignant arrhythmias, high-risk patients should be considered for an ICD as frontline therapy.
Acute intraoperative effect of intravenous amiodarone on right ventricular function in patients undergoing valvular surgery. [2017]Amiodarone is commonly used in the acute care setting. However the acute hemodynamic and echocardiographic effect of intravenous amiodarone administered intraoperatively on right ventricular (RV) systolic and diastolic function using transesophageal echocardiography (TEE) has not been described.
Amiodarone and mortality among elderly patients with acute myocardial infarction with atrial fibrillation. [2013]Amiodarone has been shown to be safe in patients with acute myocardial infarction (AMI) who are at risk for sudden cardiac death. However, there is limited data concerning the safety of amiodarone in patients who experience AMI complicated by atrial fibrillation.
Topical amiodarone during cardiac surgery: Does epicardial application of amiodarone prevent postoperative atrial fibrillation? [2019]Atrial fibrillation (AF) is a common complication after cardiac surgery. Topical amiodarone on the epicardium may help prevent postoperative AF while avoiding the side effects of its systemic administration. The purpose of this study was to evaluate the all-comer strategy of epicardial amiodarone application for the prevention of postoperative AF.