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Antiarrhythmic Agent
Amiodarone for Preventing Postoperative Atrial Fibrillation
Phase 4
Recruiting
Led By Anson Lee, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
No documented history of atrial fibrillation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
Study Summary
This trial is testing whether a medication called amiodarone can prevent a heart rhythm problem called atrial fibrillation (AF) after surgery.
Who is the study for?
This trial is for patients having their first non-emergency open-heart surgery, like bypass or valve repair, with a normal heart rhythm and no history of atrial fibrillation. It's not for those who've had previous heart surgeries using cardiopulmonary bypass, any past atrial arrhythmias lasting over 30 seconds, or prior Amiodarone use.Check my eligibility
What is being tested?
The study tests if inducing and then treating atrial fibrillation (AF) during surgery can prevent postoperative AF. Patients with inducible AF are randomly chosen to receive Amiodarone treatment or no treatment; others get standard care. The goal is to see if this method predicts and reduces post-surgery AF.See study design
What are the potential side effects?
Amiodarone may cause side effects such as skin reactions when exposed to sunlight, affecting the lungs leading to breathing issues, liver problems indicated by yellowing of the skin/eyes, thyroid disorders causing weight changes or energy levels alteration.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for my first open-heart surgery for heart issues.
Select...
I have never been diagnosed with atrial fibrillation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Decreasing the incidence of Post-Operative Atrial Fibrillation for Cardiac Surgery Patients
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Non-Inducible Atrial FibrillationExperimental Treatment1 Intervention
Amiodarone treatment if POAF seen on post-operative care unit
Group II: Inducible Atrial Fibrillation - Standard CareExperimental Treatment2 Interventions
No initial Amiodarone Treatment unless POAF seen on post operative care unit.
Group III: Inducible Atrial FibrillationActive Control2 Interventions
Treatment with Amiodarone
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Amiodarone
FDA approved
Find a Location
Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,393 Previous Clinical Trials
17,340,592 Total Patients Enrolled
18 Trials studying Atrial Fibrillation
425,045 Patients Enrolled for Atrial Fibrillation
Anson Lee, MDPrincipal InvestigatorStanford University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for my first open-heart surgery for heart issues.Your heart is beating normally.I have never been diagnosed with atrial fibrillation.I have been treated with Amiodarone for irregular heartbeats before.I have had heart surgery with cardiopulmonary bypass.I have had a heart rhythm problem lasting more than 30 seconds.I need surgery for my irregular heartbeat.
Research Study Groups:
This trial has the following groups:- Group 1: Inducible Atrial Fibrillation - Standard Care
- Group 2: Non-Inducible Atrial Fibrillation
- Group 3: Inducible Atrial Fibrillation
Awards:
This trial has 5 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any current slots available for enrollment in this trial?
"Affirmative. Clinicaltrials.gov is currently hosting details about this medical trial, which was initially posted on March 1st 2017 and updated as recently as October 12th 2021. The primary goal of the study is to find 600 participants from a single location."
Answered by AI
How many participants have opted in to this research endeavor?
"Affirmative. According to records found on clinicaltrials.gov, the recruitment process for this medical trial is ongoing; it was initially posted on March 1st 2017 and its details were most recently revised in October 2021. 600 participants are required from a single testing facility."
Answered by AI
What medical conditions can be addressed through Inducible Atrial Fibrillation?
"Inducible Atrial fibrillation is a commonly utilized treatment for atrial fibrillation, in addition to other cardiac ailments such as tachycardia, cardiothoracic surgery, and recurrent ventricular fibrillation."
Answered by AI
Has Inducible Atrial Fibrillation met all criteria for federal approval?
"The safety of Inducible Atrial fibrillation was rated a 3 out of 3, as this is an approved Phase 4 treatment and has extensive data to support its efficacy."
Answered by AI
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