RecruitingPhase 4NCT03868150

Prevention of Postop Atrial Fibrillation Through Intraoperative Inducibility of Atrial Fibrillation and Amiodarone Treatment

Assessment of Intra-Operative Atrial Fibrillation Inducibility As a Screening Tool to Prevent Post-Operative Atrial Fibrillation With Prophylaxis Amiodarone


Sponsor

Stanford University

Enrollment

600 participants

Start Date

Mar 1, 2017

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a drug called amiodarone can prevent an irregular heart rhythm called atrial fibrillation (AFib) from developing after open-heart surgery. AFib is a very common complication after heart surgery, and this trial checks if testing for it during surgery and treating it early with amiodarone helps prevent it afterward. **You may be eligible if...** - You are scheduled for your first open-heart surgery (bypass, valve repair or replacement, or aortic root repair) - Your heart is currently in a normal rhythm - You have no history of atrial fibrillation **You may NOT be eligible if...** - You have had prior open-heart surgery - You have any history of AFib, atrial flutter, or rapid heart rhythms lasting more than 30 seconds - You have previously been treated with amiodarone for heart rhythm problems - You need a procedure during surgery to treat atrial arrhythmias such as pulmonary vein isolation or the Maze procedure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAmiodarone Injection

Patients stratified into the amiodarone study group were administered amiodarone until day of discharge. Amiodarone administration began intraoperatively with the administration of a 150 mg IV amiodarone loading bolus prior to separation from coronary pulmonary bypass, followed by 1 mg/min IV amiodarone for six hours (360 mg), then 0.5 mg/min IV amiodarone for 18 hours (540 mg), then transitioned to 400 mg oral amiodarone twice a day until discharge. In total, patients in the amiodarone treatment group received 1,050mg of IV amiodarone plus 800mg/day of oral amiodarone thereafter until discharge.

DEVICEIntraoperative Rapid Atrial Pacing

Intraoperative rapid atrial pacing for 30 seconds after cannulation and prior to initiation of cardiopulmonary bypass by having the surgeon attach insulated forceps to the superior right atrial free wall and connected to a temporary pacemaker to burst pace at a rate of 800 bpm for 30 seconds (pulse width 1.0 ms, output: 20 mA) Patients are monitored for successful atrial fibrillation induction defined as 30 seconds of sustained atrial fibrillation on ECG.


Locations(1)

Stanford University

Stanford, California, United States

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NCT03868150


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