Atrial FibrillationPhase 2/3NCT05357690
A Study of Stellate Ganglion Block for Prevention of Atrial Fibrillation
A Phase 2/3 study testing Stellate ganglion block and Bupivacaine in people with Atrial Fibrillation, run by Mayo Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Stellate ganglion block and Bupivacaine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2023to 8 Jun 2026
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: 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.
Read the 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).
- Conditions
- Atrial Fibrillation
- Being tested
- Stellate ganglion block, Bupivacaine, Placebo
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stellate ganglion blockProcedure or surgery
Ultrasound guided injection into the stellate ganglion performed in the right side of the neck in a sterile fashion.
BupivacaineDrug
10 mL of 0.5% without epinephrine injected in the plane of the right stellate ganglion
PlaceboDrug
10 mL of saline injected in the plane of the right stellate ganglion
| Study group | Role | What they receive |
|---|---|---|
| Stellate ganglion block with local anesthetic | Experimental | Subjects will receive a single injection of bupivacaine in a stellate ganglion block Receives: Procedure: Stellate ganglion block; Drug: Bupivacaine |
| Stellate ganglion block with saline placebo | Sham comparator | Subjects will receive a single injection of saline in a stellate ganglion block Receives: Procedure: Stellate ganglion block; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of atrial fibrillation
Percentage of subjects to experience postoperative atrial fibrillation (POAF)
Measured: Within one week of surgery or during hospitalization if discharged prior to one week
Secondary outcomes (2)
Duration of atrial fibrillation
Duration of postoperative atrial fibrillation (POAF)
Measured: Within one week of surgery or during hospitalization if discharged prior to one week
Skin Sympathetic Nerve Activity
Measurement of difference in skin sympathetic nerve activity following block
Measured: 10-30 minute following performance of nerve block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start19 Apr 2023
- Primary completion8 Jun 2026
- Study completion8 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erica D. Wittwer, M.D., Ph.D., Mayo Clinic
- Investigators
- Erica Wittwer, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05357690
- Sponsor's protocol ID
- 22-001106
- Status last verified
- Jul 2026
- First submitted
- 27 Apr 2022
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stellate Ganglion Blockade for the Prevention of Atrial Fibrillation After Cardiac Surgery: A Randomized Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT05357690
- Acronym / sponsor ID
- 22-001106
- Conditions
- Atrial Fibrillation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 19 Apr 2023 (actual)
- Primary completion
- 8 Jun 2026 (actual)
- Study completion
- 8 Jun 2026 (actual)
- First posted
- 3 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stellate ganglion block with local anesthetic | Experimental | Procedure: Stellate ganglion block, Drug: BupivacaineSubjects will receive a single injection of bupivacaine in a stellate ganglion block |
| Stellate ganglion block with saline placebo | Sham comparator | Procedure: Stellate ganglion block, Drug: PlaceboSubjects will receive a single injection of saline in a stellate ganglion block |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stellate ganglion blockUltrasound guided injection into the stellate ganglion performed in the right side of the neck in a sterile fashion. | Procedure or surgery | Stellate ganglion block with local anesthetic, Stellate ganglion block with saline placebo |
| Bupivacaine10 mL of 0.5% without epinephrine injected in the plane of the right stellate ganglion | Drug | Stellate ganglion block with local anesthetic |
| Placebo10 mL of saline injected in the plane of the right stellate ganglion | Drug | Stellate ganglion block with saline placebo |
Primary outcome
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)
2 secondary outcomes
Duration of atrial fibrillation
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erica Wittwer, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Stellate ganglion block and Bupivacaine in people with Atrial Fibrillation, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of atrial fibrillation (time frame: Within one week of surgery or during hospitalization if discharged prior to one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.