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 @ 12:35 PM
Ignite Modification Date:
2025-12-24 @ 12:35 PM
NCT ID:
NCT04559061
Eligibility Criteria:
Inclusion Criteria:
1. Patient has one of the following clinical arrhythmia/pacing types:
* Atrial pacing
* Atrial fibrillation
* Ventricular pacing
* Premature ventricular complex
* Ventricular tachycardia
* Ventricular fibrillation
* Focal atrial tachycardia
* Premature atrial complex
* Atrioventricular reentrant tachycardia
2. Patient has undergone 'successful' routine, standard of care diagnostic electrophysiology (EP) study using intracardiac catheters as clinically indicated, guided by fluoroscopy and routine electroanatomic mapping, intracardiac echocardiography, and/or cardiac imaging such as CT or MRI.
3. Patient has 12 lead electrogram data of clinical rhythms recorded on electrogram recording system.
4. Patient has undergone a successful ablation procedure.
5. Arrhythmia type and atrial/ventricular characteristics can be abstracted from patient medical records.
6. Patient was between 22 and 100 years of age at time of EP study and ablation procedure.
Exclusion Criteria:
Patients with unstable coronary artery disease, confirmed intracardiac thrombus, active sepsis, complex congenital heart disease, dextrocardia, severe pulmonary hypertension, decompensated heart failure, a mechanical heart valve, myocardial infarction within 1 month of ablation, inability to induce arrhythmia, unacceptable ECG data quality, and/or data included in the device training dataset.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Maximum Age:
100 Years
Study:
NCT04559061
Study Brief:
Protocol Section:
NCT04559061