600 Participants Needed

Amiodarone for Preventing Postoperative Atrial Fibrillation

AL
CC
Overseen ByCody Carlton, BS
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Stanford University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

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.12345

Is 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.46789

How 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.12467

Research Team

AL

Anson Lee, MD

Principal Investigator

Stanford University

Eligibility 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.
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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

Treatment Details

Interventions

  • Amiodarone Injection
  • Intraoperative Rapid Atrial Pacing
Trial OverviewThe 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.
Participant Groups
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

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials
2,527
Recruited
17,430,000+

Findings from Research

A single-day loading dose of oral amiodarone (1200 mg) did not significantly reduce the overall incidence of postoperative atrial fibrillation in 315 patients after coronary artery bypass surgery, with similar rates in both the amiodarone and placebo groups.
However, in elderly patients (aged 60 and above), amiodarone was effective in reducing the incidence of atrial fibrillation, suggesting it may be beneficial for this specific demographic.
Single-day loading dose of oral amiodarone for the prevention of new-onset atrial fibrillation after coronary artery bypass surgery.Maras, D., Bosković, SD., Popović, Z., et al.[2013]
In a study of 120 patients undergoing cardiac valvular surgery, intravenous amiodarone did not effectively reduce the incidence of postoperative atrial fibrillation, with rates of 59.3% in the amiodarone group compared to 40.0% in the placebo group.
Four preoperative factors were identified as increasing the risk of developing postoperative atrial fibrillation: older age, recent myocardial infarction, preoperative angina, and the use of calcium channel blockers.
Perioperative intravenous amiodarone does not reduce the burden of atrial fibrillation in patients undergoing cardiac valvular surgery.Beaulieu, Y., Denault, AY., Couture, P., et al.[2013]
Intraoperative use of intravenous amiodarone did not significantly reduce the incidence of new onset atrial fibrillation after coronary artery bypass grafting, with rates of 24% in the high-dose group and 28% in the low-dose group compared to 34% in the placebo group.
Although amiodarone did not prevent atrial fibrillation, it was associated with a higher incidence of temporary atrial pacing due to bradycardia in the high-dose group, indicating potential safety concerns with its use in this context.
Intraoperative amiodarone as prophylaxis against atrial fibrillation after coronary operations.Dörge, H., Schoendube, FA., Schoberer, M., et al.[2019]

References

Single-day loading dose of oral amiodarone for the prevention of new-onset atrial fibrillation after coronary artery bypass surgery. [2013]
Perioperative intravenous amiodarone does not reduce the burden of atrial fibrillation in patients undergoing cardiac valvular surgery. [2013]
Intraoperative amiodarone as prophylaxis against atrial fibrillation after coronary operations. [2019]
Simple amiodarone protocol reduces postoperative atrial fibrillation. [2012]
Evaluation of an evidence-based practice implementation: prophylactic amiodarone following coronary artery revascularization. [2019]
Topical amiodarone during cardiac surgery: Does epicardial application of amiodarone prevent postoperative atrial fibrillation? [2019]
Effectiveness of biatrial epicardial application of amiodarone-releasing adhesive hydrogel to prevent postoperative atrial fibrillation. [2022]
Ranolazine versus amiodarone for prevention of postoperative atrial fibrillation. [2021]
Safety of amiodarone in the prevention of postoperative atrial fibrillation: a meta-analysis. [2019]