Ignite Creation Date:
2024-05-06 @ 7:34 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06056271
Status:
RECRUITING
Last Update Posted:
2024-04-24
First Post:
2023-09-20
Brief Title:
Clinical and Healthcare Outcomes From Real-World Use in the United States of a Companion AI During AF Ablation
Sponsor:
Volta Medical
Organization:
Volta Medical
Study Overview
Official Title:
Clinical and Healthcare Outcomes From Real-World Use in the United States of a Companion AI During AF Ablation
Status:
RECRUITING
Status Verified Date:
2024-04
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:
COMPANION AI
Brief Summary:
Observational multi-center clinical device registry for US patients with a primary goal to observe the clinical outcomes in patients who are mapped with Volta Medicals VX1 or AF-Explorer systems during AF ablation procedures
Detailed Description:
None
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