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

PHASE4RecruitingINTERVENTIONAL
Enrollment

600

Participants

Timeline

Start Date

March 1, 2017

Primary Completion Date

December 31, 2030

Study Completion Date

December 31, 2050

Conditions
Postoperative Atrial Fibrillation
Interventions
DRUG

Amiodarone 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.

DEVICE

Intraoperative 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.

Trial Locations (1)

94305

RECRUITING

Stanford University, Stanford

All Listed Sponsors
lead

Stanford University

OTHER