Ignite Creation Date:
2024-05-05 @ 10:25 PM
Last Modification Date:
2024-10-26 @ 10:18 AM
Study NCT ID:
NCT01103674
Status:
TERMINATED
Last Update Posted:
2014-04-03
First Post:
2010-04-13
Brief Title:
Safety and Efficacy Study of the Combined Ablation Procedure to Treat Paroxysmal Atrial Fibrillation
Sponsor:
nContact Surgical Inc
Organization:
nContact Surgical Inc
Study Overview
Official Title:
Feasibility Study For Safety and Efficacy Evaluation Of The Combined Ablation Procedure For The Treatment Of Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation
Status:
TERMINATED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
enrollment challenges only one patient enrolled
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAP STOPS AF
Brief Summary:
This is a multi-center prospective open label feasibility clinical studyevaluating the safety and efficacy of the combined ablation procedure for the treatment of symptomatic paroxysmal atrial fibrillation
Detailed Description:
The purpose of this feasibility study is to evaluate the safety and efficacy of the epicardial endocardial combined procedure for the treatment of drug refractory symptomatic Paroxysmal Atrial Fibrillation AF patients using the nContact Numeris-AF Guided Coagulation System with VisiTrax epicardially and the Biosense Webster NaviStar ThermoCool DiagnosticAblation deflectable Tip Catheter in conjunction with the Carto Navigation System endocardially
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