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 @ 2:08 PM
Ignite Modification Date:
2025-12-24 @ 2:08 PM
NCT ID:
NCT03803995
Eligibility Criteria:
Inclusion Criteria:
1. Patients are undergoing implant of an Abbott pacemaker or CRT device under standard indications
2. An ECG with a wide QRS complex (\>130 ms)
3. ECG morphology of typical complete LBBB,
4. Patients have heart failure with NYHA Class II-IV symptoms,
5. LV EF \<50%
6. At least 18 years old and not pregnant.
7. Must provide written informed consent prior to any clinical investigation related procedure.
8. Willing to comply with study evaluation requirements
9. Female subjects of child-bearing potential are required to have a negative pregnancy test done within 7 days prior to the implant procedure per site standard test. Female patients of childbearing potential should be instructed to use safe contraception (e.g., intrauterine devices, hormonal contraceptives: contraceptive pills, implants, transdermal patches hormonal vaginal devices, injections with prolonged release.)
Exclusion Criteria:
1. Patients have non-specific intraventricular conduction delay or right bundle branch block
2. Previously implanted cardiac devices with three or more permanent leads
3. History of aortic valve repair or replacement
4. History of tricuspid valve replacement
5. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
6. Recent (\< 3 months) myocardial infarction, ablation, electrolyte imbalance, or any condition within the last 90 days that would contraindicate for pacemaker or CRT implant in the opinion of the investigator
7. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03803995
Study Brief:
Protocol Section:
NCT03803995