Using a nerve block to prevent atrial fibrillation after heart surgery
Stellate Ganglion Blockade for the Prevention of Atrial Fibrillation After Cardiac Surgery: A Randomized Placebo-Controlled Trial
This study is testing if a special nerve block can help prevent heart rhythm problems after heart surgery for patients.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT05357690 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a stellate ganglion block, a nerve block procedure, in reducing the incidence and duration of postoperative atrial fibrillation (POAF) in patients undergoing cardiac surgery. Participants will receive either the nerve block with local anesthetic or a saline placebo prior to surgery. The study will assess the incidence of POAF within one week post-surgery and measure the success of the nerve block through changes in hand temperature and sympathetic nerve activity. The goal is to determine if this intervention can improve outcomes for patients undergoing heart surgery.
Who should consider this trial
Good fit: Ideal candidates are patients scheduled for mitral or aortic valve surgery at the Mayo Clinic.
Not a fit: Patients with a history of permanent atrial fibrillation or those undergoing procedures that do not require cardiopulmonary bypass may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the occurrence of atrial fibrillation after cardiac surgery, leading to better recovery outcomes for patients.
How similar studies have performed: Previous studies have indicated that stellate ganglion blockade may reduce other types of abnormal heart rhythms, suggesting potential success for this approach in preventing atrial fibrillation.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Erica Wittwer, MD — Mayo Clinic
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.