NCT05357690

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P50-P75 for phase_2 atrial-fibrillation

Timeline
7mo left

Started Apr 2023

Longer than P75 for phase_2 atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Apr 2023Dec 2026

First Submitted

Initial submission to the registry

April 27, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 3, 2022

Completed
12 months until next milestone

Study Start

First participant enrolled

April 19, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

May 14, 2025

Status Verified

May 1, 2025

Enrollment Period

3 years

First QC Date

April 27, 2022

Last Update Submit

May 10, 2025

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Incidence of atrial fibrillation

    Percentage of subjects to experience postoperative atrial fibrillation (POAF)

    Within one week of surgery or during hospitalization if discharged prior to one week

Secondary Outcomes (2)

  • Duration of atrial fibrillation

    Within one week of surgery or during hospitalization if discharged prior to one week

  • Skin Sympathetic Nerve Activity

    10-30 minute following performance of nerve block

Study Arms (2)

Stellate ganglion block with local anesthetic

EXPERIMENTAL

Subjects will receive a single injection of bupivacaine in a stellate ganglion block

Procedure: Stellate ganglion blockDrug: Bupivacaine

Stellate ganglion block with saline placebo

SHAM COMPARATOR

Subjects will receive a single injection of saline in a stellate ganglion block

Procedure: Stellate ganglion blockDrug: Placebo

Interventions

Stellate ganglion blockPROCEDURE

Ultrasound guided injection into the stellate ganglion performed in the right side of the neck in a sterile fashion.

Stellate ganglion block with local anestheticStellate ganglion block with saline placebo
BupivacaineDRUG

10 mL of 0.5% without epinephrine injected in the plane of the right stellate ganglion

Stellate ganglion block with local anesthetic
PlaceboDRUG

10 mL of saline injected in the plane of the right stellate ganglion

Stellate ganglion block with saline placebo

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Erica Wittwer, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 27, 2022

First Posted

May 3, 2022

Study Start

April 19, 2023

Primary Completion

April 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

May 14, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)