Recruiting

Amiodarone

Sponsor:

Stanford University

Code:

NCT03868150

Conditions

Postoperative Atrial Fibrillation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Amiodarone Injection

Intraoperative Rapid Atrial Pacing

Study Details

Brief 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

Conditions

Postoperative Atrial Fibrillation

Study ID

NCT03868150

Start date

Mar 1, 2017

Status verified date

Feb, 2026

Completion date

Dec 31, 2050

Anticipated

Primary completion date

Dec 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Patients scheduled for first-time non-emergent open-heart surgery for coronary artery bypass graft (CABG) revascularization, valvular repair or replacement, combined CABG with valve repair or replacement, or valve sparing aortic root repair
  • Normal sinus rhythm
  • No documented history of atrial fibrillation

Exclusion Criteria:

  • Prior surgical procedures involving heart surgery and cardiopulmonary bypass
  • Any prior documented history of atrial fibrillation, atrial flutter or atrial tachycardia lasting longer than 30 seconds
  • Prior history of Amiodarone treatment for the management of supraventricular tachy-arrhythmias
  • Patients requiring surgical treatment of atrial arrhythmias such as pulmonary vein isolation or Maze procedure.

Study Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Inducible Atrial Fibrillation

Treatment with Amiodarone

other: Inducible Atrial Fibrillation - Standard Care

No initial Amiodarone Treatment unless POAF seen on post operative care unit.

other: Non-Inducible Atrial Fibrillation

Amiodarone treatment if POAF seen on post-operative care unit

Interventions

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.

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.

Primary outcome measure

  • Decreasing the incidence of Post-Operative Atrial Fibrillation for Cardiac Surgery Patients [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Anson Lee, MD

650-724-7500ansonlee@stanford.edu

Locations

Stanford University

Recruiting

Stanford, California, United States, 94305

Contacts

Anson Lee, MD

650-724-7500

More Information

Sponsor

Stanford University

Last update posted

Feb 17, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2026-02-17.