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

NCT03868150 | Recruiting Phase 4 FDA Drug FDA Device

• 1 other identifier: 38527
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Decreasing the incidence of Post-Operative Atrial Fibrillation for Cardiac Surgery Patients

  Identify predictors of developing atrial fibrillation in the hope of decreasing post-operative length of stay, the need for anticoagulation, decrease risk of stroke, DVT, and bleeding

  30 days

Study Arms (3)

Inducible Atrial Fibrillation

ACTIVE COMPARATOR

Treatment with Amiodarone

Drug: Amiodarone Injection; Device: Intraoperative Rapid Atrial Pacing

Inducible Atrial Fibrillation - Standard Care

OTHER

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

Drug: Amiodarone Injection; Device: Intraoperative Rapid Atrial Pacing

Non-Inducible Atrial Fibrillation

OTHER

Amiodarone treatment if POAF seen on post-operative care unit

Device: Intraoperative Rapid Atrial Pacing

Interventions

Amiodarone Injection DRUG

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.

Inducible Atrial Fibrillation; Inducible Atrial Fibrillation - Standard Care

Intraoperative Rapid Atrial Pacing DEVICE

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.

Inducible Atrial Fibrillation; Inducible Atrial Fibrillation - Standard Care; Non-Inducible Atrial Fibrillation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

RECRUITING

Related Publications (1)

• Pong T, Cyr K, Niesen J, Aparicio-Valenzuela J, Carlton C, Fischbein MP, Woo YJ, Boyd JH, Lee AM. Screening and Prophylactic Amiodarone Reduces Post-Operative Atrial Fibrillation in At-Risk Patients. J Am Coll Cardiol. 2020 Mar 24;75(11):1361-1363. doi: 10.1016/j.jacc.2020.01.016. No abstract available.

  PMID: 32192666 DERIVED

MeSH Terms

Interventions

Amiodarone

Intervention Hierarchy (Ancestors)

Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Anson Lee, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anson Lee, MD

CONTACT

650-724-7500; ansonlee@stanford.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Prospective randomized control trial of Amiodarone versus standard of care in patients with intraoperative inducible atrial fibrillation undergoing non emergent first-time cardiac surgery.

Study Record Dates

• First Submitted: March 6, 2019
• First Posted: March 8, 2019
• Study Start: March 1, 2017
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2050
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

US (1)