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

NCT ID: NCT03868150

Last Updated: 2023-11-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2050-12-31

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

Detailed Description

In the operating room, as part of the open heart surgery, the surgeon will stimulate the superior right atrium section of the heart with a pacemaker for 30 seconds just prior to starting the heart and lung bypass machine. The stimulation is done to see how sensitive the heart is to developing atrial fibrillation. This test result will be documented. The procedure will only take 60 seconds out of the entire operation. It does not involve taking any samples of tissue or blood. Following this step, if the heart demonstrates atrial fibrillation for at least 30 seconds then the participant will then be randomized to either receive the prophylactic drug treatment using Amiodarone or to no prophylactic drug administration. The participant has a 50% chance of receiving the FDA approved study drug Amiodarone. The study arms consist of prophylactic drug administration with Amiodarone, No prophylactic drug administration, or no atrial fibrillation reaction after stimulation with the pacemaker. The remainder of the surgical procedure will not be affected, and will follow routine surgical practice.

Conditions

Postoperative Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Inducible Atrial Fibrillation

Treatment with Amiodarone

Group Type: ACTIVE_COMPARATOR

Amiodarone Injection

Intervention Type: 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.

Intraoperative Rapid Atrial Pacing

Intervention Type: 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 - Standard Care

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

Group Type: OTHER

Amiodarone Injection

Intervention Type: 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.

Intraoperative Rapid Atrial Pacing

Intervention Type: 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.

Non-Inducible Atrial Fibrillation

Amiodarone treatment if POAF seen on post-operative care unit

Group Type: OTHER

Intraoperative Rapid Atrial Pacing

Intervention Type: 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.

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.

Intervention Type: DRUG

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Anson M Lee

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anson Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Stanford, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Anson Lee, MD

Role: CONTACT

ansonlee@stanford.edu

650-724-7500

Facility Contacts

Anson Lee, MD

Role: primary

650-724-7500

References

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.

Reference Type: DERIVED

PMID: 32192666 (View on PubMed)

Other Identifiers

38527

Identifier Type: -

Identifier Source: org_study_id