Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT01385202
Status:
COMPLETED
Last Update Posted:
2025-02-04
First Post:
2011-06-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation
Sponsor:
Biosense Webster, Inc.
Organization:
Study Overview
Official Title:
THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation
Status:
COMPLETED
Status Verified Date:
2025-01
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:
The purpose of this study is to demonstrate the safety and effectiveness of the THERMOCOOL® SMARTTOUCH™ Catheters with Contact Force Sensing Capability in the treatment of drug refractory symptomatic paroxysmal Atrial Fibrillation (AF) during standard electrophysiology mapping and RF procedures.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: