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 @ 2:15 PM
Ignite Modification Date:
2025-12-24 @ 2:15 PM
NCT ID:
NCT03711695
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 21 years and ≤ 85 years
2. Able to understand and give informed consent.
3. Subject is presenting for the following planned procedures:
3.1 Group A (25 subjects): Subjects presenting for catheter ablation for cardiac arrhythmias (e.g. atrial fibrillation, supraventricular tachycardia, or ventricular tachycardia) 3.2 Group B (25 subjects): Subjects judged based on the clinical evaluation of high, greater than 75%, atrial pacing or ventricular pacing burden or known pacing dependence with planned device interrogation for: 1) pacemaker (single or dual chamber), 2) implantable cardioverter-defibrillator (single or dual chamber), or 3) cardiac resynchronization therapy with or without defibrillator (single or dual chamber plus left ventricular pacing).
3.3 Group C (5 subjects): Subjects for clinically indicated defibrillation threshold testing (DFT) (with a transvenous or subcutaneous ICD lead system)
Exclusion Criteria:
1. Age \< 21 years and \> 85 years
2. Unable to or refuse to give written informed consent
3. Unwilling or unable to wear the smartwatch device on at least one wrist
4. Uncorrected severe aortic stenosis or subaortic stenosis (including hypertrophic cardiomyopathy) with outflow tract obstruction \> 50 mm
5. New York Heart Association Class IV Heart Failure
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
85 Years
Study:
NCT03711695
Study Brief:
Protocol Section:
NCT03711695