Ignite Creation Date:
2024-05-06 @ 12:39 AM
Last Modification Date:
2024-10-26 @ 10:52 AM
Study NCT ID:
NCT01623492
Status:
COMPLETED
Last Update Posted:
2019-01-23
First Post:
2012-05-09
Brief Title:
Eisenmenger Quality Enhancement Research Initiative
Sponsor:
Actelion
Organization:
Actelion
Study Overview
Official Title:
Eisenmenger Quality Enhancement Research Initiative
Status:
COMPLETED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ES-QuERI
Brief Summary:
Eisenmenger Quality Enhancement Research Initiative QuERI is a multi-center observational US-based longitudinal program with enrollment of consecutive Eisenmenger patients who meet enrollment Patient data will be collected prospectively for three years Individual physician feedback will be provided on data collected with the purpose of improving the management of patients - quality enhancement research initiative QuERI process
Detailed Description:
Approximately 200 male and female adult patients with a history of Eisenmenger will be recruited from approximately 50 cardiology practices over a period of 18 months and will be followed up every six months for the period of three years Consecutive patients in each practice meeting inclusion and exclusion criteria should be considered for the study Participating sites will be asked to maintain a screening log to identify which inclusion or exclusion criteria was not met thus excluding them from the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None