Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06376851
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-19
First Post:
2024-03-28
Brief Title:
AI DErived Plaque Quantification CCTA and AI-QCPA for Determining Effective CAD Management
Sponsor:
HeartFlow Inc
Organization:
HeartFlow Inc
Study Overview
Official Title:
DECIDE Registry AI DErived Plaque Quantification CCTA and AI-QCPA for Determining Effective CAD Management
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-09
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:
DECIDE
Brief Summary:
The objective of HeartFlows DECIDE Registry is to collect observational data about the management of patients before and after HeartFlow Artificial Intelligence-Quantitative Coronary Plaque Analysis AI-QCPA
Detailed Description:
The DECIDE Registry is a post-market multi-center data collection study assessing the change in management of clinically stable patients who undergo CCTA with plaque detected Data will be retrospectively collected following the CCTA and analyses will be completed 90 days 180 days and 1 year after CCTA Data may be retrospectively collected annually up to 5 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None