Stellate Ganglion Block for Atrial Fibrillation

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Mayo Clinic

Must not be taking: Immunosuppressants, Anti-arrhythmics, Steroids

Disqualifiers: Permanent atrial fibrillation, Immunodeficiency, Neurologic disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

220 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a stellate ganglion block, a type of nerve block, can reduce the risk of developing atrial fibrillation (an irregular and fast heartbeat) after heart surgery. Participants will receive either a local anesthetic (bupivacaine) or a saline placebo injection to determine which is more effective. Ideal candidates are those preparing for mitral or aortic valve surgery at the Mayo Clinic in Rochester, Minnesota, and who do not have permanent atrial fibrillation or certain other medical conditions. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people, offering participants a chance to contribute to important medical advancements.

Will I have to stop taking my current medications?

The trial requires that you stop taking pre-operative anti-arrhythmic medications, except for beta-blockers, before participating.

What prior data suggests that the stellate ganglion block is safe for atrial fibrillation?

Research shows that the stellate ganglion block, a procedure where medication is injected near a group of nerves in the neck, is generally safe. Studies have found that patients tolerate and accept this procedure well, especially for conditions like PTSD (post-traumatic stress disorder).

In one study, patients who underwent this procedure experienced fewer irregular heartbeats and reported less pain. Another study emphasized its safety when performed with ultrasound guidance, making it a practical bedside option.

Overall, using a local anesthetic like bupivacaine in the stellate ganglion block has proven safe and effective in reducing certain irregular heart rhythms. This suggests it may help decrease atrial fibrillation, an abnormal, fast heartbeat in the upper heart chambers, after surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the stellate ganglion block for atrial fibrillation because it offers a unique approach by targeting the autonomic nervous system, which is different from the typical medications or ablation procedures currently used. The treatment involves a single injection of bupivacaine, a local anesthetic, directly into the stellate ganglion, potentially providing quick relief. Another arm of the study uses a saline placebo, which helps researchers understand the true impact of the anesthetic. This method could offer a faster and less invasive option for managing atrial fibrillation, sparking interest in its potential to change the way we approach this heart condition.

What evidence suggests that a stellate ganglion block is effective for atrial fibrillation?

This trial will compare the effectiveness of a stellate ganglion block using a local anesthetic with a saline placebo. Studies have shown that a stellate ganglion block, a type of nerve block procedure, can effectively reduce irregular heartbeats, including atrial fibrillation. In one study, patients who underwent this procedure experienced significantly fewer early heartbeats compared to those who did not. Another study found that this treatment could help with various heart rhythm problems, especially those difficult to manage with other methods. The procedure has been noted for reducing the chances of atrial fibrillation, particularly after surgery. Additionally, it may lead to lower hospital costs and shorter stays for patients. Overall, stellate ganglion block shows promise in managing atrial fibrillation by calming the heart's rhythm. ^{4 6 7 8 9}

Who Is on the Research Team?

Erica Wittwer, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Patient presenting for cardiac surgery at the Mayo Clinic in Rochester, Minnesota.

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

Exclusion 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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-surgical Treatment

Participants receive a stellate ganglion block with either bupivacaine or saline placebo prior to cardiac surgery

1 day

1 visit (in-person)

Post-surgical Monitoring

Participants are monitored for the incidence and duration of postoperative atrial fibrillation (POAF) within one week of surgery or during hospitalization

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bupivacaine
• Placebo
• Stellate ganglion block

Trial Overview 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.

How Is the Trial Designed?

Group I: Stellate ganglion block with local anesthetic Experimental Treatment 2 Interventions

Subjects will receive a single injection of bupivacaine in a stellate ganglion block

Group II: Stellate ganglion block with saline placebo Placebo Group 2 Interventions

Subjects will receive a single injection of saline in a stellate ganglion block

Stellate ganglion block is already approved in European Union, United States for the following indications:

Approved in European Union as Stellate ganglion block for:

• Refractory ventricular arrhythmias
• Rapid atrial fibrillation
• Prevention of postoperative atrial fibrillation

Approved in United States as Stellate ganglion block for:

• Refractory ventricular arrhythmias
• Rapid atrial fibrillation
• Prevention of postoperative atrial fibrillation

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

In a study of 13 patients with drug-refractory electrical storm, unilateral stellate ganglion blockade (SGB) significantly reduced the number of arrhythmias and defibrillation episodes within 96 hours after the procedure, with 62% of patients experiencing no ventricular arrhythmias and 92% having no defibrillation episodes.

Despite the reduction in arrhythmias, SGB did not impact the patients' left ventricular ejection fraction, the need for antiarrhythmic medications, or respiratory support, indicating that while SGB may help stabilize arrhythmias, it does not improve overall heart function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stellate ganglion blockade for treating refractory electrical storm: a historical cohort study. Reinertsen, E., Sabayon, M., Riso, M., et al.[2022]

In a study of 30 patients with drug-refractory electrical storm, percutaneous stellate ganglion blockade (SGB) successfully controlled ventricular arrhythmias (VA) in 60% of patients within 24 hours, significantly reducing hospital mortality rates for those whose VA was managed (5.6% vs. 50.0%).

SGB led to a remarkable 92% reduction in VA episodes in the 72 hours following the procedure, demonstrating its efficacy as a treatment option for patients who have not responded to other therapies, with no major complications reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effective Use of Percutaneous Stellate Ganglion Blockade in Patients With Electrical Storm. Tian, Y., Wittwer, ED., Kapa, S., et al.[2020]

A 59-year-old male with refractory ventricular tachycardia (VT) experienced immediate cessation of VT and maintained sinus rhythm after receiving a left stellate ganglion block (LSGB) using a lidocaine and bupivacaine solution.

The LSGB procedure appears to be a safe and effective method for controlling refractory VT, suggesting its potential as a rescue therapy before more invasive treatments like catheter ablation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Left stellate ganglion block, a rescue treatment for ventricular arrhythmia refractory to radiofrequency catheter ablation: A care-compliant case report. Yang, SC., Wu, CC., Hsieh, YJ.[2022]

Stellate ganglion blockade (SGB) can significantly reduce the frequency of refractory ventricular arrhythmias for 24-72 hours, providing a critical window for other treatments like catheter ablation or heart transplantation.

SGB is a safe procedure with a low risk of complications, even in patients on anticoagulation, making it a viable option for managing various types of ventricular arrhythmias.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stellate Ganglion Blockade: an Intervention for the Management of Ventricular Arrhythmias. Ganesh, A., Qadri, YJ., Boortz-Marx, RL., et al.[2021]

The use of GP IIb/IIIa receptor antagonists has significantly decreased the need for emergency cardiac surgeries, but it has also increased the risk of bleeding during procedures like coronary artery bypass grafting (CABG).

Current guidelines recommend specific strategies, such as delaying surgery and managing heparin dosing, to safely perform CABG on patients treated with these inhibitors, balancing the benefits of reduced heart attack rates against the surgical risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of platelet inhibitors on blood use in cardiac surgery. Lee, LY., DeBois, W., Krieger, KH., et al.[2018]

In the ORBIT Trial involving 549 patients, the oral GP IIb/IIIa antagonist xemilofiban effectively inhibited platelet aggregation over a 28-day period, demonstrating sustained pharmacodynamic efficacy.

There was a promising trend towards reduced cardiovascular events in patients receiving the highest dose of xemilofiban (20 mg), suggesting potential long-term benefits, although further confirmation is needed in larger studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacodynamic efficacy, clinical safety, and outcomes after prolonged platelet Glycoprotein IIb/IIIa receptor blockade with oral xemilofiban: results of a multicenter, placebo-controlled, randomized trial. Kereiakes, DJ., Kleiman, NS., Ferguson, JJ., et al.[2019]

Administering a platelet glycoprotein IIb/IIIa receptor blocker during percutaneous coronary intervention significantly reduces the risk of nonfatal myocardial infarction and the need for emergency stenting.

In diabetic patients receiving intracoronary stenting, these blockers also lower the likelihood of needing further procedures to reopen the target vessel, demonstrating their efficacy across various patient categories.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Platelet glycoprotein IIb/IIIa receptor blockade: lessening the risk of coronary interventions. Pitts, WR., Lange, RA.[2010]

Stellate Ganglion Block (SGB) is an effective treatment for upper extremity pain due to Chronic Regional Pain Syndrome (CRPS), and this study compared the effectiveness of ultrasound-guided SGB versus fluoroscopy-guided SGB in 14 patients.

The results indicated that ultrasound guidance for SGB is safer and leads to better improvements in patient disability indexes compared to fluoroscopic guidance, with significant reductions in pain intensity observed over six months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Stellate Ganglion Block Under Fuoroscopy or Ultrasound Guidance in Upper Extremity CRPS. Imani, F., Hemati, K., Rahimzadeh, P., et al.[2022]

The modified fluoroscopy-guided technique for stellate ganglion block (SGB) at the C7 level effectively managed chronic regional pain syndrome (CRPS-1) in nine patients without any serious complications.

This approach minimizes the risk of accidental intravascular injection of local anesthetics, ensuring safety while maintaining consistent efficacy in pain relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Revalidation of a modified and safe approach of stellate ganglion block. Jadon, A.[2022]

Ultrasonographic guidance for stellate ganglion block (SGB) resulted in a complete block in all patients, compared to 11 out of 12 with the blind technique, indicating improved efficacy.

The use of ultrasound significantly reduced complications, as no hematomas occurred with the imaging technique, while three patients experienced hematomas with the blind method, highlighting enhanced safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound imaging for stellate ganglion block: direct visualization of puncture site and local anesthetic spread. A pilot study. Kapral, S., Krafft, P., Gosch, M., et al.[2022]

In a study of 308 patients with retinal vessel obstruction, stellate ganglion block (SGB) treatment was found to significantly improve visual outcomes, indicating its effectiveness as a treatment option.

Factors such as the duration of visual impairment and the presence of diabetes mellitus also played a crucial role in determining visual prognosis, highlighting the importance of patient characteristics in treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Statistical analysis of visual prognosis following stellate ganglion block treatment on patients with retinal vessel obstruction. Sakamoto, A., Umeda, E., Gotoh, K., et al.[2019]

Stellate ganglion block (SGB) has been found effective for non-pain indications such as reducing cardiovascular sympathetic stimulation and improving blood flow in limbs, with moderate to low certainty based on 24 studies including 19 randomized controlled trials.

SGB is also recommended for alleviating menopausal symptoms like hot flashes, particularly in cases where conventional treatments have failed, although evidence for other non-pain uses remains insufficient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stellate ganglion block for non-pain indications: a scoping review. Feigin, G., Velasco Figueroa, S., Englesakis, MF., et al.[2023]

Oral xemilofiban, a GP IIb/IIIa receptor antagonist, effectively inhibited platelet aggregation by over 50% for 8 to 10 hours after doses of 10 mg or more, demonstrating sustained efficacy over a 2-week treatment period following stent deployment.

The study found no significant bleeding complications or need for blood transfusions, indicating that xemilofiban is a safe option for patients undergoing coronary interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sustained platelet glycoprotein IIb/IIIa blockade with oral xemilofiban in 170 patients after coronary stent deployment. Kereiakes, DJ., Kleiman, N., Ferguson, JJ., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12404266/

Effect of Stellate Ganglion Block on Preventing Atrial ... However, patients in the SGB group experienced significantly fewer premature atrial contractions (97 vs 347; p = 0.038), lower pain scores (VAS ...

2. jacc.org jacc.org/doi/10.1016/j.jaccas.2024.102530

Management of Rapid Atrial Fibrillation Using Stellate ... Several recent studies have demonstrated the efficacy of treating refractory ventricular arrhythmias with stellate ganglion blockade (SGB).

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05357690

A Study of Stellate Ganglion Block for Prevention of Atrial ... Stellate ganglion blockade has shown to decrease other types of abnormal heart rhythms as well as decrease the chance of atrial fibrillation. Detailed ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2405500X24000082

A Multicenter Study of Stellate Ganglion Block as ... SGB can be a useful treatment for the suppression of refractory VT/VF or electrical storm. Most data regarding SGB have been limited to small studies from ...

5. mayo.edu mayo.edu/research/clinical-trials/cls-20533569

Stellate Ganglion Block to Prevent Atrial Fibrillation in ... Stellate ganglion blockade has potential for great impact reducing the burden of POAF including large cost savings, reduction in hospital length of stay, and ...

6. academic.oup.com academic.oup.com/eurheartj/article/45/Supplement_1/ehae666.434/7838993

Efficacy and safety of ultrasound guided stellate ganglion block Our data suggest that US-guided PSGB usage, thanks to its feasibility at bed-side and good safety profile, may expand, beyond ES, to not only ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4601906/

Safety and Patient Acceptability of Stellate Ganglion ... The SGB procedure for PTSD is a safe, well-tolerated, and acceptable treatment adjunct in the management of severe symptoms associated with chronic treatment- ...

8. ahajournals.org ahajournals.org/doi/10.1161/CIRCEP.118.007118

Effective Use of Percutaneous Stellate Ganglion Blockade ... Acute Outcomes of SGB ... At 24 hours after SGB, 60% of patients were free of VA (46.7% after left SGB and 53.3% after bilateral SGB; P=1.00).

9. clinicaltrials.gov clinicaltrials.gov/study/NCT05656170

Study Details | Stellate Ganglion to Prevent Atrial Fibrillation Pre-operative stellate ganglion block, in addition to beta blockade, will reduce post-operative atrial fibrillation in cardiac surgery patients. Specific aims:.