Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06529978
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-24
Brief Title:
Endocardial Mapping With the CoreMap EP Mapping System
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Endocardial Mapping With the CoreMap Electrophysiology Mapping System for Persistent Atrial Fibrillation Protocol
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INvENI
Brief Summary:
This is a global multi-site prospective feasibility study
Detailed Description:
The INvENI Study consists of two phases For Phase 1 the goal is to collect and analyze high fidelity endocardial EGMs in patients with persistent and long-standing persistent AF The Phase 2 goal is the initial development and evaluation of a CoreMap-guided tailored ablation strategy
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