A Study Of Stellate Ganglion Blockade With Liposomal Bupivacaine In Preventing Atrial Fibrillatio… (NCT07570940) | Clinical Trial Compass
Not Yet RecruitingPhase 4
A Study Of Stellate Ganglion Blockade With Liposomal Bupivacaine In Preventing Atrial Fibrillation After Isolated Coronary Artery Bypass Grafting Surgery
United States450 participantsStarted 2026-06
Plain-language 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 wearable ECG devices.
Who can participate
Age range40 Years
SexALL
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Inclusion Criteria:
* 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.
Exclusion criteria:
* 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).
* 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 enrol…
What they're measuring
1
Incidence of new-onset postoperative atrial fibrillation (POAF) within one week of isolated coronary artery bypass grafting (CABG) surgery
Timeframe: 1 week
Trial details
NCT IDNCT07570940
SponsorMayo Clinic
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2030-06
Contact for this trial
Anesthesia Clinical Research Unit (ACRU) Study Team