Ignite Creation Date:
2024-05-06 @ 5:56 PM
Last Modification Date:
2024-10-26 @ 2:38 PM
Study NCT ID:
NCT05481359
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-01
First Post:
2022-07-28
Brief Title:
AF-FLOW Registry This Study is to Evaluate Ablamap Software in Patients Undergoing Ablation for Atrial Fibrillation
Sponsor:
Ablacon Inc
Organization:
Cortex
Study Overview
Official Title:
A Post Market Global Registry to Evaluate the Identification of Atrial Fibrillation Sources Using the Ablamap Electrographic FLOW EGF Mapping System to Guide Ablation Therapy in Patients With Atrial Fibrillation
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-11
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:
This post-market global registry will evaluate the ability of the Ablamap Software to identify atrial fibrillation sources and guide ablation therapy in patients with atrial fibrillation
Detailed Description:
The AF-FLOW Registry is a prospective multi-center global post-market registry that will obtain clinical data in order to characterize the performance of the Ablamap Software for its intended use in a real-world setting Specifically we will evaluate the ability of the Ablamap Software to identify AF sources and guide ablation therapy in patients with atrial fibrillation This registry will enroll up to 100 subjects Subjects that present with atrial fibrillation and meet inclusionexclusion criteria will be eligible for enrollment
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?:
True
Is an FDA AA801 Violation?:
None