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 @ 3:11 AM
Ignite Modification Date:
2025-12-25 @ 3:11 AM
NCT ID:
NCT04595305
Eligibility Criteria:
Inclusion Criteria:
* Subjects are 18 years of age or older, or of legal age to give informed consent specific to state and national law
* Subject must provide written informed consent prior to any clinical investigation related procedure
* Subjects who are undergoing implantation of an Abbott CRT-P or CRT-D device under standard indications
* Subjects are treated with optimal pharmacological therapy (as determined by the site principle investigator) for a minimum 4 weeks prior to procedure
* ECG showing Sinus Rhythm (SR)
* LBBB morphology with QRS duration \>130ms
* Subject should be willing and able to comply with the prescribed follow-up schedule of evaluations.
* Female subjects of child-bearing potential should have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.
Exclusion Criteria:
* Subjects with a life expectancy less than the duration of the study
* Subjects with medical conditions that preclude the testing required for all patients by the study protocol or that otherwise limit study participation required for all patients
* Subjects with mechanical tricuspid or aortic heart valves
* Inaccessibility for follow-up at the study centre
* Unwillingness or inability to provide written informed consent
* Enrollment in, or intention to participate in, another clinical study during the course of this study excluding a registry
* Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04595305
Study Brief:
Protocol Section:
NCT04595305