Amiodarone for Preventing Postoperative Atrial Fibrillation
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Stanford University
Must not be taking: Amiodarone
Disqualifiers: Prior heart surgery, Atrial fibrillation, others
No Placebo Group
Prior Safety Data
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?Patients undergoing first time cardiac surgery will undergo rapid atrial pacing prior to initiation of cardiopulmonary bypass to screen for AF inducibility. Patients with inducible AF will be randomized to prophylactic amiodarone treatment versus no treatment. Patients who are not inducible to AF will be treated with standard post-operative care. Patients will be monitored post-operatively to explore the value of intraoperative inducibility of AF to predict POAF and to evaluate whether the combination of intraoperative inducibility and precision amiodarone therapy is effective at reducing the incidence of POAF
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the drug Amiodarone Injection, Cordarone, Nexterone, Pacerone for preventing postoperative atrial fibrillation?
Research shows that using amiodarone, either orally or intravenously, can help prevent atrial fibrillation (a type of irregular heartbeat) after heart surgery, reducing complications and hospital stay length.
12345Is amiodarone safe for preventing postoperative atrial fibrillation?
Amiodarone is commonly used to prevent atrial fibrillation after surgery, but it can have significant side effects outside the heart, so it is usually given to high-risk patients. Some studies suggest that applying it directly to the heart during surgery might help avoid these side effects.
46789How is the drug Amiodarone Injection unique in preventing postoperative atrial fibrillation?
Amiodarone Injection is unique because it can be administered intravenously during and after surgery, which may help prevent postoperative atrial fibrillation more effectively than oral forms, and it can be applied topically to the heart to avoid systemic side effects.
12467Eligibility Criteria
This trial is for patients having their first non-emergency open-heart surgery, like bypass or valve repair, with a normal heart rhythm and no history of atrial fibrillation. It's not for those who've had previous heart surgeries using cardiopulmonary bypass, any past atrial arrhythmias lasting over 30 seconds, or prior Amiodarone use.Inclusion Criteria
I am scheduled for my first open-heart surgery for heart issues.
Your heart is beating normally.
I have never been diagnosed with atrial fibrillation.
Exclusion Criteria
I have been treated with Amiodarone for irregular heartbeats before.
I have had heart surgery with cardiopulmonary bypass.
I have had a heart rhythm problem lasting more than 30 seconds.
+1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1 week
1 visit (in-person)
Intraoperative Assessment
Rapid atrial pacing is performed to assess AF inducibility prior to cardiopulmonary bypass
1 day
During surgery
Treatment
Participants with inducible AF are randomized to receive prophylactic Amiodarone or no treatment
Immediate post-operative period
Follow-up
Participants are monitored for the incidence of post-operative atrial fibrillation and other outcomes
30 days
Regular monitoring during hospital stay and follow-up visits
Participant Groups
The study tests if inducing and then treating atrial fibrillation (AF) during surgery can prevent postoperative AF. Patients with inducible AF are randomly chosen to receive Amiodarone treatment or no treatment; others get standard care. The goal is to see if this method predicts and reduces post-surgery AF.
3Treatment groups
Experimental Treatment
Active Control
Group I: Non-Inducible Atrial FibrillationExperimental Treatment1 Intervention
Amiodarone treatment if POAF seen on post-operative care unit
Group II: Inducible Atrial Fibrillation - Standard CareExperimental Treatment2 Interventions
No initial Amiodarone Treatment unless POAF seen on post operative care unit.
Group III: Inducible Atrial FibrillationActive Control2 Interventions
Treatment with Amiodarone
Amiodarone Injection is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Cordarone for:
- Life-threatening ventricular arrhythmias
- Ventricular fibrillation
- Pulseless ventricular tachycardia
🇪🇺 Approved in European Union as Cordarone for:
- Life-threatening ventricular arrhythmias
- Ventricular fibrillation
- Pulseless ventricular tachycardia
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Stanford UniversityStanford, CA
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Who Is Running the Clinical Trial?
Stanford UniversityLead Sponsor
References
Single-day loading dose of oral amiodarone for the prevention of new-onset atrial fibrillation after coronary artery bypass surgery. [2013]Various regimens have been proposed for the prevention of postoperative atrial fibrillation, including the use of intravenous and oral amiodarone. The purpose of this study was to determine the effectiveness of a single-day loading dose of oral amiodarone in prophylaxis of atrial fibrillation during the 7 days after coronary artery bypass 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.
Intraoperative amiodarone as prophylaxis against atrial fibrillation after coronary operations. [2019]New onset of atrial fibrillation is a frequent complication after coronary artery bypass grafting and is a major cause of postoperative morbidity. Preoperative oral treatment with amiodarone hydrochloride has been shown to be efficacious as prophylaxis. The present study investigated whether intraoperative use of intravenous amiodarone has a preventive effect on the incidence of atrial fibrillation after coronary revascularization.
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).
Evaluation of an evidence-based practice implementation: prophylactic amiodarone following coronary artery revascularization. [2019]Postoperative atrial fibrillation is the most frequent dysrhythmia following coronary artery bypass grafting and is associated with complications, additional therapy, and longer hospital stays. Prophylactic amiodarone protocols have been validated as safe and beneficial in the prevention of atrial fibrillation following cardiac surgery. This study evaluates the use of our current treatment protocol, given prophylactically, as feasible and effective in producing similar outcomes in postoperative atrial fibrillation reduction as well as identifies any perioperative risk factors associated with this arrhythmia.
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.
Effectiveness of biatrial epicardial application of amiodarone-releasing adhesive hydrogel to prevent postoperative atrial fibrillation. [2022]Postoperative atrial fibrillation (POAF) is the most frequent complication arising after cardiac surgery, occurring in 30% of cases. Amiodarone is the most effective drug for prophylaxis and treatment. However, because of significant extracardiac side effects, only high-risk patients are eligible for prophylactic amiodarone therapy. We performed a randomized prospective study of 100 patients undergoing cardiac surgery with epicardial application of amiodarone-releasing hydrogel to determine the effectiveness of preventing POAF.
Ranolazine versus amiodarone for prevention of postoperative atrial fibrillation. [2021]Postoperative atrial fibrillation (AF) is a major complication of cardiothoracic surgery, leading to significant consequences, including a higher rate of stroke, longer hospital stays and increased costs. Amiodarone is among the most widely used agents for prevention of postoperative AF. Ranolazine, a US FDA-approved antianginal agent, has been shown to effectively, safely prevent and terminate nonpostoperative AF in both experimental and clinical studies. In a recent publication, Miles and colleagues directly compared the efficacy and safety of amiodarone and ranolazine for prevention of postoperative AF in 393 patients. The patients were pretreated with amiodarone and ranolaizne for >1 week and 1 day, respectively, and the treatment continued for 10-14 days after surgery. Following coronary artery bypass grafting (CABG), AF occurred in 26.5% of patients taking amiodarone and in 17.5% of patients taking ranolazine (34% reduction; p
Safety of amiodarone in the prevention of postoperative atrial fibrillation: a meta-analysis. [2019]A meta-analysis was conducted to assess the safety of amiodarone in the prevention of postoperative atrial fibrillation.