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 @ 7:58 PM
Ignite Modification Date:
2025-12-24 @ 7:58 PM
NCT ID:
NCT04359004
Eligibility Criteria:
Inclusion Criteria:
* Presence of structural heart disease as defined as EF ≤ 50% or presence of ventricular scar as detected by imaging modalities or electroanatomic mapping, hypertrophic cardiomyopathy, cardiac sarcoidosis, or arrhythmogenic right ventricular cardiomyopathy.
* Age \> 18 years old
* Underlying sinus rhythm with heart rate \> 50 bpm.
* Provision of signed/dated informed consent and stated willingness to comply with all study procedures
Exclusion Criteria:
* Active ongoing cardiac ischemia as assessed by: ECG, cardiac enzymes, symptoms, coronary angiography with evidence of significant epicardial coronary stenosis (\>70%), or stress testing. (Note: positive troponin assay due to Internal Cardiac Defibrillator (ICD) shocks is not an exclusion criterion).
* Status post orthotopic heart transplantation
* Women who are pregnant (as evidenced by pregnancy test if pre-menopausal).
* Unable or unwilling to comply with protocol requirements.
* Known channelopathy such as long QT syndrome, Brugada syndrome, and catecholaminergic polymorphic VT.
* Known peripheral neuropathy or history of autonomic dysfunction due to non-cardiac causes.
* New York Heart Association Class IV heart failure or use of current vasopressor medications
* Incessant VT
* Persistent atrial fibrillation
* Frequent premature atrial or ventricular contractions
* Inability to give informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04359004
Study Brief:
Protocol Section:
NCT04359004