Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:39 PM
Ignite Modification Date:
2025-12-24 @ 6:39 PM
NCT ID:
NCT04514757
Eligibility Criteria:
Inclusion Criteria:
1. Patients scheduled to undergo coronary artery bypass surgery, major vascular/aneurysm repair requiring bypass, valvular replacement or repair, or both, for clinically indicated reasons.
2. Age ≥ 18 years.
3. Sinus rhythm at baseline.
4. Provision of signed informed consent and stated willingness to comply with all study procedures for duration of the study
Exclusion Criteria:
1. Emergent surgery
2. Anticipated amiodarone use
3. Patients with permanent or persistent atrial fibrillation
4. Planned concomitant atrial Maze procedure
5. Complex congenital heart disease
6. Women who are pregnant (as evidenced by pregnancy test if pre-menopausal).
7. Left ventricular assist device or status post orthotopic heart or lung transplantation
8. Unable or unwilling to comply with protocol requirements.
9. Known channelopathy such as Brugada syndrome, long QT syndrome, or Catecholaminergic monomorphic ventricular tachycardia
10. Symptomatic sinus bradycardia or sinus node dysfunction at baseline without an implantable pacemaker.
11. Complete heart block or trifascicular block without an implantable pacemaker
12. Recurrent vasovagal syncope
13. Unilateral or bilateral vagotomy
14. Chronic amiodarone use
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04514757
Study Brief:
Protocol Section:
NCT04514757