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:
2025-12-25 @ 3:22 AM
Ignite Modification Date:
2025-12-25 @ 3:22 AM
NCT ID:
NCT05462405
Eligibility Criteria:
Inclusion Criteria:
* Subject is already implanted with a Moderato IPG that can be used to deliver CNT pacing signals, whether CNT pacing was activated or not.
* Subject is willing and able to comply with the study and procedures.
Exclusion Criteria:
* Subject is dependent on 100% ventricular pacing.
* Subject has symptoms of heart failure, NYHA Class III or greater.
* Subject has an ejection fraction of 25% or less
* Subject's systolic blood pressure is less than 100 mm Hg on the day of recording.
* Subject has decompensated heart failure
* Subject has significant (\>3+) mitral regurgitation, aortic regurgitation, or aortic stenosis
* Subject has permanent atrial fibrillation.
* Subject has Atrial fibrillation on the day of the study.
* Subject has hypertrophic cardiomyopathy, restrictive cardiomyopathy, or interventricular septal thickness ≥15 mm.
* Subject is on dialysis
* Subject has prior neurological events (stroke or TIA) within the past year or a neurological event (stroke) at any prior time that has resulted in residual neurologic deficit.
* Subject has a history of autonomic dysfunction.
* Women who are pregnant or breast-feeding.
* Subject cannot or is unwilling to provide informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05462405
Study Brief:
Protocol Section:
NCT05462405