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 @ 3:56 PM
Ignite Modification Date:
2025-12-24 @ 3:56 PM
NCT ID:
NCT03305692
Eligibility Criteria:
Inclusion Criteria:
* Willing and able to provide informed consent for participation in the study
* Age ≥18 years
* Received a first-time CRT device for standard clinical indication (can be upgraded from non-CRT pacemaker or defibrillator if ventricular pacing \< 10%)
* Adequate echocardiographic images for EF \& LVESV determination
Exclusion Criteria:
* Unhealed open wounds on the torso and/or a history of documented severe allergic reactions from ECG electrode gel
* Enrollment in a concurrent study that could confound the results of this study
* Pregnant or could become pregnant within the 6 month follow-up period
* Non-ischemic cardiomyopathy, LBBB morphology, and QRSd \> 150 ms
* Dysrhythmia (AF or PVCs) that will likely result in aggregate ventricular pacing \< 90% over the 6 month follow-up period
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
110 Years
Study:
NCT03305692
Study Brief:
Protocol Section:
NCT03305692