Atrial FibrillationPhase 3NCT07893275
SGB for Prevention of Postop A-Fib After Cardiac SurgeryTrial
A Phase 3 study testing Stellate Ganglion Block Injection with 10 mL 0.5% Bupivacaine and Stellate Ganglion Block Injection with 10 mL Normal Saline in people with Atrial Fibrillation and Postoperative Atrial Fibrillation, run by The Cleveland Clinic.
Trial summary
This research study is being conducted to determine whether a stellate ganglion block, a small injection in the neck that temporarily reduces sympathetic nervous system activity, can help reduce the risk of developing postoperative atrial fibrillation after cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Postoperative Atrial Fibrillation
- What is being tested?
- Stellate Ganglion Block Injection with 10 mL 0.5% Bupivacaine and Stellate Ganglion Block Injection with 10 mL Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2026to Nov 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing cardiac surgery with cardiopulmonary bypass (any: valve ± CABG ± aorta)
- Sinus Rhythm preoperatively
Who cannot join
- Preoperative atrial fibrillation or flutter (both paroxysmal and permanent)
- Permanent pacemaker or ICD
- Planned MAZE/PVI, LAAO (LAAO excluded due to effect on risk of POAF)
- Contraindication to regional anesthesia or SGB (infection, coagulopathy, allergy)
- Hemodynamic instability precluding safe SGB
- Circulatory arrest
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- Pericardiectomy
- Pulmonary thrombendarterectomy
- Transplants
- VADs
- Percutaneous procedures
- Emergency surgery
- Refusal to participate Percutaneous procedures
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Stellate Ganglion Block for the Prevention of Postoperative Atrial Fibrillation After Cardiac Surgery-Pilot & Feasibility Randomized Trial
This research study is being conducted to determine whether a stellate ganglion block, a small injection in the neck that temporarily reduces sympathetic nervous system activity, can help reduce the risk of developing postoperative atrial fibrillation after cardiac surgery.
Postoperative atrial fibrillation is a common complication after cardiac surgery and may lead to longer hospital stays and other health problems. This study is also being conducted to evaluate whether this procedure can be performed safely and feasibly in cardiac surgery patients.
Read more
The medication used in the active treatment group is bupivacaine, which is approved by the U.S. Food and Drug Administration (FDA). However, its use as part of a stellate ganglion block for prevention of atrial fibrillation after cardiac surgery is considered investigational.
The study procedure will take place after surgery while participants are in the intensive care unit (ICU), before the breathing tube is removed.
If enrolled in the study, participants will receive a single injection in the neck area while still under sedation, using ultrasound guidance, which is a type of imaging that helps the doctor see the area and place the injection safely This procedure is called a stellate ganglion block. The procedure itself takes approximately 10-15 minutes.
Before and after the procedure, the study team will perform simple measurements to assess the effect of the block. These include measuring skin temperature and checking your size. These assessments will take about 10-15 minutes.
Heart rhythm will be monitored as part of standard care during hospital stay. The study team will collect information about development atrial fibrillation within 7 days after surgery.
Read the detailed description
This study is a prospective, single-center, randomized, triple blinded, placebo-controlled pilot and feasibility trial designed to evaluate the feasibility, safety, and preliminary outcome variance of prophylactic stellate ganglion block in cardiac surgery patients.
This pilot feasibility trial will assess 1) recruitment rate (patients' and surgeons' willingness to participate); 2) optimize procedural success assessment and data collection methods; 3) estimate variability and effect size to ultimately inform the design of a large-scale, high-impact clinical trial evaluating SGB in postoperative cardiac surgery as a prophylactic measure for POAF in high risk POAF patient population.
- Being tested
- Stellate Ganglion Block Injection with 10 mL 0.5% Bupivacaine, Stellate Ganglion Block Injection with 10 mL Normal Saline
- Keywords
- Cardiac Surgery, Cardiopulmonary bypass, Stellate ganglion block, SG block
- 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 Block Injection with 10 mL 0.5% BupivacaineDrug
Also called Active Compator
Participants will be randomized to receive left-sided stellate ganglion block with 10 mL of 0.5% bupivacaine).
Stellate Ganglion Block Injection with 10 mL Normal SalineDrug
Also called IV fluids
Patient will receive 10mL normal saline injection.
| Study group | Role | What they receive |
|---|---|---|
| Intervention with bupivacaine | Active comparator | Participants will receive 10 mL of 0.5% bupivacaine under ultrasound guidance at the C6 level prior to extubation. Receives: Drug: Stellate Ganglion Block Injection with 10 mL 0.5% Bupivacaine |
| Sham Ganglion Block Normal Saline | Placebo comparator | Patients will receive equivalent volume of normal saline (10mL.) Receives: Drug: Stellate Ganglion Block Injection with 10 mL Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of treatment
POAF incidence within the first seven postoperative days
Measured: 24months
Study Feasibility
successful recruitment and treatment with absence of serious adverse events associated with block procedure
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionNov 2027 (estimated)
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 The Cleveland 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized 1:1 to received either a left-sided stellate ganglion block with 10 mL of 0.5% preservative-free bupivacaine or a left-sided sham block with an equivalent volume of saline (10 mL).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marta Kelava, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07893275
- Sponsor's protocol ID
- 26-700
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stellate Ganglion Block for the Prevention of Postoperative Atrial Fibrillation After Cardiac Surgery-Pilot & Feasibility Randomized Trial
- ClinicalTrials.gov ID
- NCT07893275
- Acronym / sponsor ID
- 26-700
- Keywords
- Cardiac Surgery, Cardiopulmonary bypass, Stellate ganglion block, SG block
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 23 Oct 2026 (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.
This research study is being conducted to determine whether a stellate ganglion block, a small injection in the neck that temporarily reduces sympathetic nervous system activity, can help reduce the risk of developing postoperative atrial fibrillation after cardiac surgery.
Postoperative atrial fibrillation is a common complication after cardiac surgery and may lead to longer hospital stays and other health problems. This study is also being conducted to evaluate whether this procedure can be performed safely and feasibly in cardiac surgery patients.
The medication used in the active treatment group is bupivacaine, which is approved by the U.S. Food and Drug Administration (FDA). However, its use as part of a stellate ganglion block for prevention of atrial fibrillation after cardiac surgery is considered investigational.
The study procedure will take place after surgery while participants are in the intensive care unit (ICU), before the breathing tube is removed.
If enrolled in the study, participants will receive a single injection in the neck area while still under sedation, using ultrasound guidance, which is a type of imaging that helps the doctor see the area and place the injection safely This procedure is called a stellate ganglion block. The procedure itself takes approximately 10-15 minutes.
Before and after the procedure, the study team will perform simple measurements to assess the effect of the block. These include measuring skin temperature and checking your size. These assessments will take about 10-15 minutes.
Heart rhythm will be monitored as part of standard care during hospital stay. The study team will collect information about development atrial fibrillation within 7 days after surgery.
Detailed description
This study is a prospective, single-center, randomized, triple blinded, placebo-controlled pilot and feasibility trial designed to evaluate the feasibility, safety, and preliminary outcome variance of prophylactic stellate ganglion block in cardiac surgery patients.
This pilot feasibility trial will assess 1) recruitment rate (patients' and surgeons' willingness to participate); 2) optimize procedural success assessment and data collection methods; 3) estimate variability and effect size to ultimately inform the design of a large-scale, high-impact clinical trial evaluating SGB in postoperative cardiac surgery as a prophylactic measure for POAF in high risk POAF patient population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Participants will be randomized 1:1 to received either a left-sided stellate ganglion block with 10 mL of 0.5% preservative-free bupivacaine or a left-sided sham block with an equivalent volume of saline (10 mL).
| Arm | Type | Receives |
|---|---|---|
| Intervention with bupivacaine | Active comparator | Drug: Stellate Ganglion Block Injection with 10 mL 0.5% BupivacaineParticipants will receive 10 mL of 0.5% bupivacaine under ultrasound guidance at the C6 level prior to extubation. |
| Sham Ganglion Block Normal Saline | Placebo comparator | Drug: Stellate Ganglion Block Injection with 10 mL Normal SalinePatients will receive equivalent volume of normal saline (10mL.) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Undergoing cardiac surgery with cardiopulmonary bypass (any: valve ± CABG ± aorta)
- Sinus Rhythm preoperatively
Key exclusion criteria (13 listed)
- Preoperative atrial fibrillation or flutter (both paroxysmal and permanent)
- Permanent pacemaker or ICD
- Planned MAZE/PVI, LAAO (LAAO excluded due to effect on risk of POAF)
- Contraindication to regional anesthesia or SGB (infection, coagulopathy, allergy)
- Hemodynamic instability precluding safe SGB
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 Block Injection with 10 mL 0.5% BupivacaineAlso: Active CompatorParticipants will be randomized to receive left-sided stellate ganglion block with 10 mL of 0.5% bupivacaine). | Drug | Intervention with bupivacaine |
| Stellate Ganglion Block Injection with 10 mL Normal SalineAlso: IV fluidsPatient will receive 10mL normal saline injection. | Drug | Sham Ganglion Block Normal Saline |
Primary outcome
Success of treatment
Time frame: 24months
POAF incidence within the first seven postoperative days
Study Feasibility
Time frame: 24 months
successful recruitment and treatment with absence of serious adverse events associated with block procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
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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.
Marta Kelava, MD principal investigator
The Cleveland Clinic
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Stellate Ganglion Block Injection with 10 mL 0.5% Bupivacaine and Stellate Ganglion Block Injection with 10 mL Normal Saline in people with Atrial Fibrillation and Postoperative Atrial Fibrillation, run by The Cleveland Clinic.
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 13 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: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 phase mean?
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Research Coordinator (2166456928, harbeim@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of treatment (time frame: 24months). The study lists 2 primary outcomes in all. 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 27 Oct 2026.