Investigating nerve activity in the heart during surgery
Synaptic Plasticity in the Epicardial Ganglionated Plexi
This study is testing how nerve activity in the heart affects heart rhythm during surgery in patients with atrial fibrillation.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 21 Years to 90 Years |
| Sex | All |
| Sponsor | University of Oklahoma Academic / other |
| Locations | 1 site (Oklahoma City, Oklahoma) |
| Trial ID | NCT05034419 on ClinicalTrials.gov |
What this trial studies
This clinical trial focuses on understanding the role of synaptic plasticity in the epicardial ganglionated plexi in patients with atrial fibrillation. It aims to explore how the autonomic nervous system, particularly the ganglionated plexus, influences heart rhythm during open heart surgery. Participants will receive either parasympathetic or sham stimulation to assess changes in nerve activity and its potential impact on atrial fibrillation. The study is designed for patients who are scheduled for elective open heart surgery, allowing for controlled observation of these mechanisms.
Who should consider this trial
Good fit: Ideal candidates for this study are male and female patients over 21 years old who are scheduled for elective open heart surgery.
Not a fit: Patients undergoing emergent open heart surgery may not benefit from this study due to the nature of their surgical needs.
Why it matters
Potential benefit: If successful, this study could lead to improved management and treatment strategies for patients with atrial fibrillation.
How similar studies have performed: While the specific approach of this study is novel, previous studies have indicated the importance of the autonomic nervous system in atrial fibrillation, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male and female patients older than 21 year old 2. Patient is going to have open heart surgery. Exclusion Criteria: 1. Patients undergoing emergent open heart surgery.
Where this trial is running
Oklahoma City, Oklahoma
- OU Medical Center — Oklahoma City, Oklahoma, United States (Recruiting)
Study contacts
- Study coordinator: Stavros Stavrakis
- Email: stavros-stavrakis@ouhsc.edu
- Phone: 4052714742
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.