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:
2025-12-25 @ 12:52 AM
Ignite Modification Date:
2025-12-25 @ 11:07 PM
NCT ID:
NCT03735667
Pre Assignment Details:
The non-randomized Roll-in phase with only the test device was for centers with no previous experience implanting ACURATE. Each applicable site performed at least two Roll-in cases before starting enrollment in the Main Randomized Cohort.
Only data for the Main Randomized Cohort and Roll-in Cohort are being reported at this time as data for the 4D-CT Substudy and other 3 cohorts (Continued Access Study, Extended Durability, and Prime XL Nested Registry) are not available.
Recruitment Details:
Main Randomized Cohort: 1500 subjects randomized from 10Jun2019 to 19Apr2023. Roll-in Cohort: 148 subjects enrolled from 10Jul2019 to 27Feb2023.
Study:
NCT03735667
Study Brief:
Results Section:
NCT03735667