NCT05357690 A Study of Stellate Ganglion Block for Prevention of Atrial Fibrillation
| NCT ID | NCT05357690 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Mayo Clinic |
| Condition | Atrial Fibrillation |
| Study Type | INTERVENTIONAL |
| Enrollment | 220 participants |
| Start Date | 2023-04-19 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 220 participants in total. It began in 2023-04-19 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. Stellate ganglion blockade has shown to decrease other types of abnormal heart rhythms as well as decrease the chance of atrial fibrillation.
Eligibility Criteria
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.
Contact & Investigator
Erica Wittwer, MD
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT05357690 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05357690 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05357690 currently recruiting?
Yes, NCT05357690 is actively recruiting participants. Visit ClinicalTrials.gov or contact Mayo Clinic to inquire about joining.
Where is the NCT05357690 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT05357690 clinical trial?
NCT05357690 is sponsored by Mayo Clinic. The principal investigator is Erica Wittwer, MD at Mayo Clinic. The trial plans to enroll 220 participants.
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