Participant Flow Module
The Participant Flow Module provides information about the flow of participants through each stage of the clinical trial. This includes pre-assignment details, recruitment information, and the types of units analyzed, helping researchers understand how participants move through the study.
Participant Flow Module path is as follows:
Study -> Results Section -> Participant Flow Module
Participant Flow Module
Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2025-12-25 @ 1:24 PM
NCT ID:
NCT04089059
Pre Assignment Details:
Of the 738 enrolled subjects, 528 received an implant, 125 had screen failure and 85 were withdrawn prior to implant. Of 85 withdrawn subjects, in 37 instances the implant procedure was aborted prior to deploying the implant. Of 528 subjects implanted, 72 were in the control group (eliminated in trial redesign). The remaining 456 patients form the mITT population, which was used for all efficacy analyses. All safety analyses used the ITT population (456 mITT + 37 withdrawn = 493 patients).
Recruitment Details:
Enrollment was initiated on January 10, 2020, and completed on March 9, 2023, among 77 sites in the United States and five (5) sites in Ireland and Belgium. The last implant procedure was performed on March 31, 2023. The patient population consisted of male and female patients, ≥ 18 years of age with a diagnosis of NYHA Class III HF who met the study patient selection criteria.
Study:
NCT04089059
Study Brief:
Results Section:
NCT04089059