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

Stanford University

Status and phase: Enrolling; Phase 4

Conditions: Postoperative Atrial Fibrillation

Treatments: Device: Intraoperative Rapid Atrial Pacing; Drug: Amiodarone Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT03868150

38527

Details and patient eligibility

About

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

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 3 patient groups

Inducible Atrial Fibrillation

Active Comparator group

Description:

Treatment with Amiodarone

Treatment:

Device: Intraoperative Rapid Atrial Pacing

Drug: Amiodarone Injection

Inducible Atrial Fibrillation - Standard Care

Other group

Description:

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

Treatment:

Device: Intraoperative Rapid Atrial Pacing

Drug: Amiodarone Injection

Non-Inducible Atrial Fibrillation

Other group

Description:

Amiodarone treatment if POAF seen on post-operative care unit

Treatment:

Device: Intraoperative Rapid Atrial Pacing