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 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:44 AM
NCT ID:
NCT02031302
Pre Assignment Details:
Lotus Valve cohort: 1 subject had the 1 year visit on 25SEP2015, but died on 02OCT2015, that's why the disposition table only shows 115 subjects died prior to 1 year Follow-up performed . A total of 116 subjects died through 1 year (365 days) post procedure (as treated population). 120 of 1002 patients died according to the ITT population.
Recruitment Details:
There were 1014 subjects enrolled at 41 centers in Germany, UK, Italy, Colombia, Finland, The Netherlands, Poland, Spain, Israel, New Zealand, Norway, Sweden and Switzerland between 27 May 2014 and 01 Feb 2016.
50 subjects were enrolled in the cohort with the Lotus Depth Guard valve between 13 Jun 2016 and 31 Oct 2016.
Study:
NCT02031302
Study Brief:
Results Section:
NCT02031302