A Study of Stellate Ganglion Block for Prevention of Atrial Fibrillation

June 1, 2026 updated by: Erica D. Wittwer, M.D., Ph.D., Mayo Clinic

Stellate Ganglion Blockade for the Prevention of Atrial Fibrillation After Cardiac Surgery: A Randomized Placebo-Controlled 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The investigator hypothesizes that stellate ganglion blockade with local anesthetic performed prior to cardiac surgery will reduce the incidence and duration of postoperative atrial fibrillation (POAF).

Specific Aim 1: Determine the incidence of POAF in patients receiving pre-surgical stellate ganglion blockade with local anesthetic versus saline placebo within one week of surgery or during hospitalization if discharged prior to one week.

Specific Aim 2: Determine the duration of POAF in patients receiving pre-surgical stellate ganglion blockade with local anesthetic versus saline placebo within one week of surgery or during hospitalization if discharged prior to one week.

Specific Aim 3: Determine the success rate of the block as evaluated by ipsilateral hand temperature change and skin sympathetic nerve activity (SKNA).

Study Type

Interventional

Enrollment (Estimated)

220

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic in Rochester
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient presenting for cardiac surgery at the Mayo Clinic in Rochester, Minnesota.
  • Patients scheduled to undergo mitral or aortic valve surgery with or without coronary artery bypass grafting.

Exclusion Criteria:

  • Patients with a history of permanent atrial fibrillation, left or right ventricular assist device implantation or explantation.
  • Patients with procedures not requiring cardiopulmonary bypass.
  • Patients with procedures requiring deep hypothermic circulatory arrest.
  • Patients with active infection or sepsis.
  • Pre-operative immunosuppressive medication use (including steroid use).
  • Pre-operative anti-arrhythmic medication use (aside from beta-blockers).
  • Patients with Immunodeficiency syndrome.
  • Patients with known neurologic disorder.
  • Patients requiring left internal jugular central line placement.
  • Performance of Maze procedures or left atrial appendage ligation procedures will not exclude patients from potential enrollment as atrial fibrillation still occurs postoperatively while the scarring from the Maze procedure forms.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stellate ganglion block with local anesthetic
Subjects will receive a single injection of bupivacaine in a stellate ganglion block
Procedure: Stellate ganglion block
Ultrasound guided injection into the stellate ganglion performed in the right side of the neck in a sterile fashion.
Drug: Bupivacaine
10 mL of 0.5% without epinephrine injected in the plane of the right stellate ganglion
Sham Comparator: Stellate ganglion block with saline placebo
Subjects will receive a single injection of saline in a stellate ganglion block
Procedure: Stellate ganglion block
Ultrasound guided injection into the stellate ganglion performed in the right side of the neck in a sterile fashion.
Drug: Placebo
10 mL of saline injected in the plane of the right stellate ganglion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of atrial fibrillation
Time Frame: Within one week of surgery or during hospitalization if discharged prior to one week
Percentage of subjects to experience postoperative atrial fibrillation (POAF)
Within one week of surgery or during hospitalization if discharged prior to one week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of atrial fibrillation
Time Frame: Within one week of surgery or during hospitalization if discharged prior to one week
Duration of postoperative atrial fibrillation (POAF)
Within one week of surgery or during hospitalization if discharged prior to one week
Skin Sympathetic Nerve Activity
Time Frame: 10-30 minute following performance of nerve block
Measurement of difference in skin sympathetic nerve activity following block
10-30 minute following performance of nerve block

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Erica Wittwer, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 19, 2023

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

April 27, 2022

First Submitted That Met QC Criteria

April 27, 2022

First Posted (Actual)

May 3, 2022

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-001106

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Atrial Fibrillation

Clinical Trials on Stellate ganglion block

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe