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 @ 4:27 AM
Ignite Modification Date:
2025-12-25 @ 4:27 AM
NCT ID:
NCT03504020
Eligibility Criteria:
Inclusion Criteria:
* Indicated for CRT, with QRS duration ≥130 ms, and planned to be implanted with a market-released Medtronic CRT device with AdaptivCRT and a Medtronic quadripolar LV lead.
* Meets at least one of the following criteria: QRS duration \< 150 ms, Prior documented Myocardial Infarction, Non-LBBB
* LVEDD ≥ 55 mm, as determined by site
Exclusion Criteria:
* Permanent/persistent AF or presenting with AF
* Pre-existing or previous LV lead or other confounding devices e.g. Left Ventricular Assist Device, Vagal Nerve Stimulator
* Currently implanted with IPG or ICD with \> 10% RV pacing
* Permanent complete AV block
* Enrolled in a concurrent study that may confound the results of this study. Pre-approval from the study manager is required for enrollment of a patient that is in a concurrent study.
* Less than 1 year life expectancy
* Vulnerable adults
* Younger than 18 years of age
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03504020
Study Brief:
Protocol Section:
NCT03504020