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

Primary Purpose

Postoperative Atrial Fibrillation

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Amiodarone Injection
Intraoperative Rapid Atrial Pacing
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Stanford UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Other

Other

Arm Label

Inducible Atrial Fibrillation

Inducible Atrial Fibrillation - Standard Care

Non-Inducible Atrial Fibrillation

Arm Description

Treatment with Amiodarone

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

Amiodarone treatment if POAF seen on post-operative care unit

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 6, 2019
Last Updated
October 12, 2021
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT03868150
Brief Title
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

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
December 31, 2030 (Anticipated)
Study Completion Date
December 31, 2050 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Atrial Fibrillation

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Inducible Atrial Fibrillation
Arm Type
Active Comparator
Arm Description
Treatment with Amiodarone
Arm Title
Inducible Atrial Fibrillation - Standard Care
Arm Type
Other
Arm Description
No initial Amiodarone Treatment unless POAF seen on post operative care unit.
Arm Title
Non-Inducible Atrial Fibrillation
Arm Type
Other
Arm Description
Amiodarone treatment if POAF seen on post-operative care unit
Intervention Type
Drug
Intervention Name(s)
Amiodarone Injection
Intervention Description
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
Device
Intervention Name(s)
Intraoperative Rapid Atrial Pacing
Intervention Description
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 Information:
Title
Decreasing the incidence of Post-Operative Atrial Fibrillation for Cardiac Surgery Patients
Description
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
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anson Lee, MD
Phone
650-724-7500
Email
ansonlee@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anson Lee, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anson Lee, MD
Phone
650-724-7500
First Name & Middle Initial & Last Name & Degree
John Niesen, RN, MSN
First Name & Middle Initial & Last Name & Degree
Terrence Pong, MD, PhD
First Name & Middle Initial & Last Name & Degree
Kevin Cyr, BS
First Name & Middle Initial & Last Name & Degree
Joy Aparicio, BS
First Name & Middle Initial & Last Name & Degree
Cody Carlton, BS

12. IPD Sharing Statement

Citations:
PubMed Identifier
32192666
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.
Results Reference
derived

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

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