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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
Must not have
Patients with procedures requiring deep hypothermic circulatory arrest.
Pre-operative immunosuppressive medication use (including steroid use).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within one week of surgery or during hospitalization if discharged prior to one week

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.
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.
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 below
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I am scheduled for heart valve surgery, possibly with a bypass.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have undergone or will undergo a procedure involving deep cooling and stopping of blood flow.
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I am taking immunosuppressive drugs, including steroids, before surgery.
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I am taking medication for heart rhythm problems, not including beta-blockers.
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I need a central line placed in my left internal jugular vein.
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My surgery did not involve stopping my heart and lungs.
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I do not have an active infection or sepsis.
Select...
I have a known neurological disorder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10-30 minute following performance of nerve block
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10-30 minute following performance of nerve block for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of atrial fibrillation
Secondary study objectives
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
~720

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,360 Previous Clinical Trials
3,065,721 Total Patients Enrolled
32 Trials studying Atrial Fibrillation
13,328 Patients Enrolled for Atrial Fibrillation
Erica Wittwer, MDPrincipal InvestigatorMayo Clinic

Media Library

Stellate ganglion block Clinical Trial Eligibility Overview. Trial Name: NCT05357690 — Phase 2 & 3
Atrial Fibrillation Research Study Groups: Stellate ganglion block with local anesthetic, Stellate ganglion block with saline placebo
Atrial Fibrillation Clinical Trial 2023: Stellate ganglion block Highlights & Side Effects. Trial Name: NCT05357690 — Phase 2 & 3
Stellate ganglion block 2023 Treatment Timeline for Medical Study. Trial Name: NCT05357690 — Phase 2 & 3
~29 spots leftby Apr 2025
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