Stellate Ganglion Block for Atrial Fibrillation
Recruiting in Palo Alto (17 mi)
Overseen byErica Wittwer, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2 & 3
Recruiting
Sponsor: Mayo Clinic
Must not be taking: Immunosuppressants, Anti-arrhythmics, Steroids
Disqualifiers: Permanent atrial fibrillation, Immunodeficiency, Neurologic disorder, others
No Placebo Group
Prior Safety Data
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?The purpose of this study is to test if a nerve block procedure called a stellate ganglion block can help decrease the chance of atrial fibrillation after surgery. Atrial fibrillation is the abnormal, fast beating of the upper chambers of the heart. Stellate ganglion blockade has shown to decrease other types of abnormal heart rhythms as well as decrease the chance of atrial fibrillation.
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 data supports the effectiveness of the treatment Stellate Ganglion Block for Atrial Fibrillation?
Stellate Ganglion Block (SGB) has been shown to be effective in managing pain conditions like Chronic Regional Pain Syndrome (CRPS) and has also been used for electrical storm due to ventricular arrhythmia, suggesting it may help with heart rhythm issues.
12345Is stellate ganglion block (SGB) generally safe for humans?
The research on stellate ganglion block (SGB) for retinal vessel obstruction suggests it is a viable treatment, but it does not provide specific safety data. However, the study does not report any safety concerns, implying it may be generally safe for use in humans.
678910How is the stellate ganglion block treatment different from other treatments for atrial fibrillation?
Stellate ganglion block (SGB) is unique because it involves blocking sympathetic nerve signals, which can help manage heart rhythm issues like atrial fibrillation. Unlike typical drug treatments, SGB is a procedure that targets the nervous system directly, offering a novel approach for patients who may not respond well to standard medications.
15111213Eligibility Criteria
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.
+7 more
Trial Timeline
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
Participant Groups
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.
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
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Mayo Clinic in RochesterRochester, MN
Loading ...
Who Is Running the Clinical Trial?
Mayo ClinicLead Sponsor
References
Stellate ganglion block for non-pain indications: a scoping review. [2023]Stellate ganglion block (SGB) is performed to relieve head, face, neck, or upper limb pain, and several non-pain indications for performing this block have emerged over the years. To date, there has been no attempt to synthesize evidence on SGB for treating non-pain indications. This scoping review presents a summary of the efficacy and adverse effects of SGB when performed for 6 non-pain indications.
Effectiveness of Stellate Ganglion Block Under Fuoroscopy or Ultrasound Guidance in Upper Extremity CRPS. [2022]Stellate Ganglion Block (SGB) is an effective technique which may be used to manage upper extremities pain due to Chronic Regional Pain Syndrome (CRPS), in this study we tried to evaluate the effectiveness of this procedure under two different guidance for management of this syndrome.
Revalidation of a modified and safe approach of stellate ganglion block. [2022]Stellate ganglion block (SGB) is very effective in management of chronic regional pain syndrome (CRPS-1). However, serious complication may occur due to accidental intravascular (intra-arterial) injection of local anaesthetic agents. Abdi and others, has suggested a modified technique in which fluoroscopy-guided block is given at the junction of uncinate process and body of vertebra at C7 level. In this approach vascular structures remain away from the trajectory of needle and thus avoid accidental vascular injection. We have used this technique of SGB in nine patients who were treated for CRPS-I. The blocks were effective in all the patients all the time without any vascular or other serious complication.
Ultrasound imaging for stellate ganglion block: direct visualization of puncture site and local anesthetic spread. A pilot study. [2022]Stellate ganglion block (SGB) inhibits sympathetic innervation and is a common treatment for reflex sympathetic dystrophy. During the positioning of the needle, there is a risk of injury to the adjacent structures. The aim of the study was to develop an ultrasonographic imaging technique for the performance of SGB.
Effective Use of Percutaneous Stellate Ganglion Blockade in Patients With Electrical Storm. [2020]Percutaneous stellate ganglion blockade (SGB) has been used for drug-refractory electrical storm due to ventricular arrhythmia (VA); however, the effects and long-term outcomes have not been well studied.
The effects of platelet inhibitors on blood use in cardiac surgery. [2018]Platelet inhibition via glycoprotein (GP) IIb/IIIa receptor antagonists has greatly reduced the need for emergent cardiac surgery. However, this change has come at a cost to both the patient and the cardiac surgical team in terms of increased bleeding risk. Current guidelines for patients requiring coronary artery bypass surgery include: 1) cessation of GP IIb/IIIa inhibitor; 2) delay of surgery for up to 12 h if abciximab, tirofiban, or eptafibitide is used; 3) utilization of ultrafiltration via zero balance technique; 4) maintenance of standard heparin dosing despite elevated bleeding times; and 5) transfusion of platelets as needed, rather than prophylactically. These agents present cardiac surgery teams with increased risk during CABG, although overall risk may be diminished by the substantial benefits to patients with acute coronary syndromes and percutaneous interventions, i.e., reduced infarction rates and improved vessel patency. With judicious planning, urgent coronary artery bypass can be safely performed on patients who have been treated with GP IIb/IIIa receptor inhibitors.
Statistical analysis of visual prognosis following stellate ganglion block treatment on patients with retinal vessel obstruction. [2019]The visual outcome in 308 patients treated for retinal vessel obstruction was examined retrospectively and the effectiveness of each treatment was evaluated using stepwise multiple linear regression analysis and the chi-square test. Visual acuity was used as the parameter for assessing treatment effectiveness and the variables investigated included treatment factors [stellate ganglion block (SGB), urokinase administration, and prostaglandin administration] and patient factors (age, duration of visual impairment before treatment, hypertension, and diabetes mellitus). SGB treatment, the duration of visual impairment, and the presence of diabetes mellitus were significantly correlated with the visual prognosis following treatment. These results support the current hypothesis that SGB is a viable treatment for patients with obstructive disease of the retinal vessels.
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. [2019]Parenteral administration of platelet glycoprotein IIb/IIIa (GP IIb/IIIa) receptor blockers can reduce ischemic complications of coronary angioplasty. Orally active GP IIb/IIIa blockers may allow more sustained receptor antagonism with the potential for long-term secondary prevention. The pharmacodynamic efficacy, clinical safety, and outcomes after prolonged receptor blockade with an orally active GP IIb/IIIa antagonist are not known. The Oral Glycoprotein IIb/IIIa Receptor Blockade to Inhibit Thrombosis (ORBIT) Trial is a multicenter, placebo-controlled, randomized trial of xemilofiban, an oral platelet GP IIb/IIIa blocking agent, administered to patients after percutaneous coronary intervention.
Sustained platelet glycoprotein IIb/IIIa blockade with oral xemilofiban in 170 patients after coronary stent deployment. [2019]Inhibition of platelet aggregation with parenteral glycoprotein (GP) IIb/IIIa receptor blockers can reduce the ischemic complications of angioplasty. Sustained efficacy and safety of protracted GP IIb/IIIa blockade with an orally administered agent have not previously been determined. This study is the first randomized, dose-ranging, single-blind, placebo-controlled trial of xemilofiban, an oral platelet GP IIb/IIIa receptor antagonist, administered to patients after intracoronary stent deployment. The pharmacodynamic efficacy of xemilofiban-induced platelet inhibition and clinical safety of this agent was evaluated during chronic therapy.
Platelet glycoprotein IIb/IIIa receptor blockade: lessening the risk of coronary interventions. [2010]For the patient undergoing percutaneous coronary intervention, the administration of a platelet glycoprotein IIb/IIIa receptor blocker reduces the incidence of a periprocedural nonfatal myocardial infarction and the need for unplanned emergency stenting. In the diabetic patient undergoing intracoronary stenting, the use of a platelet glycoprotein IIb/IIIa receptor blocker appears to decrease the need for subsequent target vessel revascularization. There is considerable evidence in support of the use of glycoprotein IIb/IIIa receptor inhibitors in all categories of patients--"high-risk" patients, "low-risk" patients, and those undergoing primary angioplasty for acute myocardial infarction--and for the full armamentarium of percutaneous procedures (angioplasty, directional atherectomy, rotational atherectomy, and intracoronary stenting).
Left stellate ganglion block, a rescue treatment for ventricular arrhythmia refractory to radiofrequency catheter ablation: A care-compliant case report. [2022]Stellate Ganglion Block (SGB) provides a blockade of sympathetic signals from the sympathetic chain and appears to be a promising method of controlling refractory ventricular arrhythmias, but there are scanty data in the literature.
Stellate Ganglion Blockade: an Intervention for the Management of Ventricular Arrhythmias. [2021]To highlight the indications, procedural considerations, and data supporting the use of stellate ganglion blockade (SGB) for management of refractory ventricular arrhythmias.
Stellate ganglion blockade for treating refractory electrical storm: a historical cohort study. [2022]Stellate ganglion blockade (SGB) has been used to treat electrical storm (ES) refractory to antiarrhythmic therapy or to stabilize patients before more definitive intervention. Nevertheless, its efficacy is not well understood, with only a few case reports and retrospective case series in the literature.