Ignite Creation Date:
2024-05-06 @ 2:54 PM
Last Modification Date:
2024-10-26 @ 1:40 PM
Study NCT ID:
NCT04468334
Status:
COMPLETED
Last Update Posted:
2024-03-12
First Post:
2020-07-08
Brief Title:
aMAZE Trial Continued Access Protocol
Sponsor:
AtriCure Inc
Organization:
AtriCure Inc
Study Overview
Official Title:
Non-randomized Multicenter Expanded Use Evaluation of the LARIAT Suture Delivery Device Appendix 16 to Ongoing Investigation
Status:
COMPLETED
Status Verified Date:
2023-04
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:
aMAZE CAP
Brief Summary:
aMAZE CAP is an extension to the current aMAZE Trial investigation IDEG150107NCT02517397Protocol Appendix 16 in the form of a nested non-randomized registry to allow ongoing treatment of subjects and the collection of additional safety and effectiveness data at existing aMAZE investigational sites
Detailed Description:
For consistency aMAZE CAP primary and secondary safety and efficacy endpoints eligibility criteria and follow up visit assessments remain unchanged from the current aMAZE Trial investigation NCT02517397
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?:
None
Is an FDA AA801 Violation?:
None