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Stellate Ganglion Block for Atrial Fibrillation
Phase 2 & 3
Recruiting
Led By Erica Wittwer, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients scheduled to undergo mitral or aortic valve surgery with or without coronary artery bypass grafting.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within one week of surgery or during hospitalization if discharged prior to one week
Awards & highlights
Study Summary
This trial will test if a stellate ganglion block can help decrease the chance of atrial fibrillation after surgery.
Who is the study for?
This trial is for patients at the Mayo Clinic in Rochester, Minnesota who are scheduled for mitral or aortic valve surgery, with or without coronary artery bypass grafting. It's not for those with permanent atrial fibrillation, ventricular assist devices, surgeries not using cardiopulmonary bypass, deep hypothermic circulatory arrest procedures, active infections or sepsis, immunosuppressive medication use (except beta-blockers), immunodeficiency syndromes, known neurological disorders, or needing left internal jugular central line placement.Check my eligibility
What is being tested?
The study tests if a stellate ganglion block—a nerve block procedure—can reduce the risk of atrial fibrillation after heart surgery. Participants will either receive this block with bupivacaine (an anesthetic) or a placebo to compare effectiveness against abnormal fast heartbeats post-surgery.See study design
What are the potential side effects?
Potential side effects from the stellate ganglion block may include discomfort at injection site and risks associated with local anesthetics like bupivacaine such as numbness around the neck area and difficulty swallowing.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for heart valve surgery, possibly with a bypass.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10-30 minute following performance of nerve block
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10-30 minute following performance of nerve block
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of atrial fibrillation
Secondary outcome measures
Duration of atrial fibrillation
Skin Sympathetic Nerve Activity
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Stellate ganglion block with local anestheticExperimental Treatment2 Interventions
Subjects will receive a single injection of bupivacaine in a stellate ganglion block
Group II: Stellate ganglion block with saline placeboPlacebo Group2 Interventions
Subjects will receive a single injection of saline in a stellate ganglion block
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bupivacaine
2013
Completed Phase 4
~1530
Stellate ganglion block
2021
N/A
~630
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,206 Previous Clinical Trials
3,766,864 Total Patients Enrolled
32 Trials studying Atrial Fibrillation
13,368 Patients Enrolled for Atrial Fibrillation
Erica Wittwer, MDPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have undergone or will undergo a procedure involving deep cooling and stopping of blood flow.I am taking immunosuppressive drugs, including steroids, before surgery.I have had a Maze procedure or left atrial appendage ligation but still experience atrial fibrillation.You have a history of permanent atrial fibrillation, or have had a left or right ventricular assist device implanted or removed.I am taking medication for heart rhythm problems, not including beta-blockers.You have a weakened immune system.I need a central line placed in my left internal jugular vein.I am scheduled for heart valve surgery, possibly with a bypass.My surgery did not involve stopping my heart and lungs.I do not have an active infection or sepsis.I have a known neurological disorder.
Research Study Groups:
This trial has the following groups:- Group 1: Stellate ganglion block with local anesthetic
- Group 2: Stellate ganglion block with saline placebo
Awards:
This trial has 0 awards, including: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 people with the required qualifications still able to sign up for this experiment?
"As can be seen on clinicaltrials.gov, this particular trial is not presently looking for new patients as recruitment has closed. The first posting was on December 1st, 2022 and the most recent edit was on September 21st, 2022. Although this specific trial is no longer recruiting, there are 501 other trials that are currently doing so."
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Who else is applying?
What portion of applicants met pre-screening criteria?
Did not meet criteria
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