Ignite Creation Date:
2024-05-06 @ 12:46 AM
Last Modification Date:
2024-10-26 @ 10:54 AM
Study NCT ID:
NCT01659411
Status:
COMPLETED
Last Update Posted:
2019-01-23
First Post:
2012-07-12
Brief Title:
Adult Congenital Heart Disease Registry QuERI
Sponsor:
Actelion
Organization:
Actelion
Study Overview
Official Title:
Adult Congenital Heart Disease 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:
None
Brief Summary:
Multi-center observational US-based longitudinal program Data will be collected prospectively for 3 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 from adult patients enrolled with a history of repaired Congenital Heart Disease CHD
Detailed Description:
Approximately 800 male and female adult patients with a history of repaired CHD will be recruited from approximately 100 cardiology practices and will be followed up every twelve months for the period of three years Consecutive patients in each practice meeting inclusion and exclusion criteria should be considered for the study Two groups of subjects will be enrolled based on identical exclusion criteria and inclusion criteria with the exception only of inclusion criteria 3 cohort 1- those demonstrating historic high risk criteria and cohort 2 - those demonstrating current high risk criteria
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CHRC2011-ACHD001 | OTHER | Canadian Identifier | None |