Coronary Artery DiseasePhase 4NCT07570940
A Study Of Stellate Ganglion Blockade With Liposomal Bupivacaine In Preventing Atrial Fibrillation After Isolated Coronary Artery Bypass Grafting Surgery
A Phase 4 study testing Liposomal bupivacaine in people with Coronary Artery Disease and Atrial Fibrillation, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is assess the incidence of postoperative atrial fibrillation (POAF) within one week of surgery in patients who receive pre-surgical stellate ganglion blockade with liposomal bupivacaine, compared to those receiving a saline placebo, using continuous electrocardiographic monitoring via… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Coronary Artery Disease, Atrial Fibrillation
- What is being tested?
- Liposomal bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2026to Sep 2030
- Phase
- Phase 4
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged ≥40 years scheduled to undergo isolated coronary artery bypass grafting will be eligible.
- Cases will also remain eligible if, after the initial surgical listing, additional procedures-such as valvular interventions or septal myectomy-are performed, OR if coronary artery bypass grafting (CABG) is listed as the primary intervention with other procedures noted as possible additional interventions.
- Cases will also remain eligible if additional procedures-such as left atrial appendage ligation, MAZE procedure, cryotherapy, or pulmonary vein isolation-are concomitantly listed with the CABG.
Who cannot join
- Permanent atrial fibrillation
- Mechanical circulatory support implant or explant
- Procedures not requiring cardiopulmonary bypass
- Heart and/or lung transplant patients
- Active infection/sepsis
- Pre-operative anti-arrhythmic use (aside from beta-blockers).
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- Participant has a known allergy to adhesives or hydrogels.
- Participant has a visible skin injury or broken skin at the location for study device placement.
- Participant does not have the competency to wear the device for the prescribed patching period.
- Participant has a neuro-stimulator, as it may disrupt the quality of ECG data.
- Participants who are pregnant. In accordance with Mayo Clinic's standard cardiac surgery protocol, all women of childbearing potential undergo routine preoperative pregnancy testing. Pregnancy status will therefore be confirmed prior to enrollment. Any participant with a positive pregnancy test will be deemed ineligible and will not be enrolled in the study.
- Participants who lack the capacity to provide informed consent will not be approached or enrolled in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Effectiveness Of Liposomal Bupivacaine Stellate Ganglion Blockade In Preventing Atrial Fibrillation After Isolated Coronary Artery Bypass Grafting Surgery: A Randomized Placebo-Controlled Trial
The purpose of this study is assess the incidence of postoperative atrial fibrillation (POAF) within one week of surgery in patients who receive pre-surgical stellate ganglion blockade with liposomal bupivacaine, compared to those receiving a saline placebo, using continuous electrocardiographic monitoring via wearable ECG devices.
- Conditions
- Coronary Artery Disease, Atrial Fibrillation
- Being tested
- Liposomal bupivacaine, Placebo
- Medical subject headings
- Coronary Artery Disease, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal bupivacaineDrug
Patients undergoing isolated coronary artery bypass grafting will receive a stellate ganglion block using liposomal bupivacaine prior to surgery
PlaceboDrug
Patients undergoing isolated coronary artery bypass grafting will receive a saline placebo injection to the stellate ganglion prior to surgery
| Study group | Role | What they receive |
|---|---|---|
| Stellate ganglion block using liposomal bupivacaine | Experimental | 10 mL of liposomal bupivacaine 133 mg (133 mg/10 ml or 1.33%) Receives: Drug: Liposomal bupivacaine |
| Sham block using saline placebo | Placebo comparator | 10 mL of saline placebo injected in the plane of the right stellate ganglion Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of new-onset postoperative atrial fibrillation (POAF) within one week of isolated coronary artery bypass grafting (CABG) surgery
Total number of patients to experience postoperative atrial fibrillation within one week of CABG surgery.
Measured: 1 week
Secondary outcomes (2)
Total duration of postoperative atrial fibrillation (POAF) episodes within the first postoperative week
Duration of postoperative atrial fibrillation episodes will assessed via continuous ECG monitoring and reported in minutes
Measured: 1 week
Number of patients with successful stellate ganglion blockade
Success rate of the stellate ganglion blockade is defined as a ≥1.0°C increase in ipsilateral hand skin temperature from baseline and/or a reduction in skin sympathetic nerve activity (SKNA) as measured by noninvasive surface recordings pre- and post-block.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start14 Sep 2026 (estimated)
- Primary completionSep 2030 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Ripoll Sanz, Mayo Clinic
- Investigators
- Juan G. Ripoll Sanz, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07570940
- Sponsor's protocol ID
- 25-009333
- Status last verified
- Sep 2026
- First submitted
- 30 Apr 2026
- Last updated
- 9 Sep 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 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Of Liposomal Bupivacaine Stellate Ganglion Blockade In Preventing Atrial Fibrillation After Isolated Coronary Artery Bypass Grafting Surgery: A Randomized Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07570940
- Acronym / sponsor ID
- 25-009333
- Conditions
- Coronary Artery Disease, Atrial Fibrillation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 14 Sep 2026 (estimated)
- Primary completion
- Sep 2030 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 6 May 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.
The purpose of this study is assess the incidence of postoperative atrial fibrillation (POAF) within one week of surgery in patients who receive pre-surgical stellate ganglion blockade with liposomal bupivacaine, compared to those receiving a saline placebo, using continuous electrocardiographic monitoring via wearable ECG devices.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stellate ganglion block using liposomal bupivacaine | Experimental | Drug: Liposomal bupivacaine10 mL of liposomal bupivacaine 133 mg (133 mg/10 ml or 1.33%) |
| Sham block using saline placebo | Placebo comparator | Drug: Placebo10 mL of saline placebo injected in the plane of the right stellate ganglion |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged ≥40 years scheduled to undergo isolated coronary artery bypass grafting will be eligible.
- Cases will also remain eligible if, after the initial surgical listing, additional procedures-such as valvular interventions or septal myectomy-are performed, OR if coronary artery bypass grafting (CABG) is listed as the primary intervention with other procedures noted as possible additional interventions.
- Cases will also remain eligible if additional procedures-such as left atrial appendage ligation, MAZE procedure, cryotherapy, or pulmonary vein isolation-are concomitantly listed with the CABG.
Key exclusion criteria (12 listed)
- Permanent atrial fibrillation
- Mechanical circulatory support implant or explant
- Procedures not requiring cardiopulmonary bypass
- Heart and/or lung transplant patients
- Active infection/sepsis
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 |
|---|---|---|
| Liposomal bupivacainePatients undergoing isolated coronary artery bypass grafting will receive a stellate ganglion block using liposomal bupivacaine prior to surgery | Drug | Stellate ganglion block using liposomal bupivacaine |
| PlaceboPatients undergoing isolated coronary artery bypass grafting will receive a saline placebo injection to the stellate ganglion prior to surgery | Drug | Sham block using saline placebo |
Primary outcome
Incidence of new-onset postoperative atrial fibrillation (POAF) within one week of isolated coronary artery bypass grafting (CABG) surgery
Time frame: 1 week
Total number of patients to experience postoperative atrial fibrillation within one week of CABG surgery.
2 secondary outcomes
Total duration of postoperative atrial fibrillation (POAF) episodes within the first postoperative week
Time frame: 1 week
Number of patients with successful stellate ganglion blockade
Time frame: 1 week
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 9 Sep 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.
Juan G. Ripoll Sanz, 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 4 study testing Liposomal bupivacaine in people with Coronary Artery Disease and 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 3 inclusion and 12 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 9 Sep 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Anesthesia Clinical Research Unit (ACRU) Study Team (866-265-9263, ripollsanz.juan@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of new-onset postoperative atrial fibrillation (POAF) within one week of isolated coronary artery bypass grafting (CABG) surgery (time frame: 1 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 9 Sep 2026.