Amiodarone for Preventing Postoperative Atrial Fibrillation
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?
Is amiodarone safe for preventing postoperative atrial fibrillation?
How is the drug Amiodarone Injection unique in preventing postoperative atrial fibrillation?
Research Team
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Intraoperative Assessment
Rapid atrial pacing is performed to assess AF inducibility prior to cardiopulmonary bypass
Treatment
Participants with inducible AF are randomized to receive prophylactic Amiodarone or no treatment
Follow-up
Participants are monitored for the incidence of post-operative atrial fibrillation and other outcomes
Treatment Details
Interventions
- Amiodarone Injection
- Intraoperative Rapid Atrial Pacing
Amiodarone Injection is already approved in United States, European Union for the following indications:
- Life-threatening ventricular arrhythmias
- Ventricular fibrillation
- Pulseless ventricular tachycardia
- Life-threatening ventricular arrhythmias
- Ventricular fibrillation
- Pulseless ventricular tachycardia
Find a Clinic Near You
Who Is Running the Clinical Trial?
Stanford University
Lead Sponsor