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 @ 7:52 PM
Ignite Modification Date:
2025-12-24 @ 7:52 PM
NCT ID:
NCT04682704
Eligibility Criteria:
Inclusion Criteria:
1. Male and female patients older than 21 year old
2. Healthy volunteers free from diagnosis of AF, heart failure, coronary artery disease or diseases that affect the autonomic nervous system.
3. Patients with Paroxysmal Atrial Fibrillation
4. Patients with Heart Failure with Preserved Ejection Fraction (HFpEF)
Exclusion Criteria:
1. Recent (\<6 months) stroke
2. Recent (\<6 months) myocardial infarction
3. Heart failure (NYHA class III or IV)
4. Left ventricular ejection fraction \<50%
5. Recurrent vaso-vagal syncopal episodes
6. Unilateral or bilateral vagotomy
7. Pregnancy or breast feeding
8. Uncontrolled diabetes or hypertension
9. Inability or unwillingness to understand and/or sign informed consent
10. Any serious disease that affects autonomic nervous system function
11. Any medications that affect autonomic nervous system function
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
90 Years
Study:
NCT04682704
Study Brief:
Protocol Section:
NCT04682704