Ignite Creation Date:
2025-12-24 @ 3:07 PM
Ignite Modification Date:
2026-01-01 @ 7:08 PM
Study NCT ID:
NCT00950092
Status:
TERMINATED
Last Update Posted:
2014-04-03
First Post:
2009-07-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
nContactSurgical Numeris-AF Tethered Coagulation System for Treatment of Persistent & LSP AF
Sponsor:
nContact Surgical Inc.
Organization:
Study Overview
Official Title:
Numeris-AF Tethered Coagulation System With VisiTrax Indicated For Treatment of Persistent and Longstanding Persistent Atrial Fibrillation
Status:
TERMINATED
Status Verified Date:
2013-09
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:
None
Brief Summary:
This is a multi center, non-randomized, prospective, open label, clinical trial evaluating the safety and efficacy of the nContact Surgical Numeris-AF Tethered Coagulation System when used to treat patients with persistent and longstanding persistent AF during concomitant cardiac surgery.
Detailed Description:
The purpose of this study is to determine the safety and efficacy of the Numeris-AF Tethered Coagulation System with VisiTrax when used to treat persistent and longstanding persistent Atrial Fibrillation(AF)during concomitant cardiac surgery.
Study Oversight
Has Oversight DMC:
True
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?: