Clinical trial NCT03868150: Prevention of Postop Atrial Fibrillation Through Intraoperative Inducibility of Atrial Fibrillation and Amiodarone Treatment
Official title: Assessment of Intra-Operative Atrial Fibrillation Inducibility As a Screening Tool to Prevent Post-Operative Atrial Fibrillation With Prophylaxis Amiodarone
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Postoperative Atrial Fibrillation
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2019-03-08
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized control trial of Amiodarone versus standard of care in patients with intraoperative inducible atrial fibrillation undergoing non emergent first-time cardiac surgery.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Decreasing the incidence of Post-Operative Atrial Fibrillation for Cardiac Surgery Patients
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Anson Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.