Ignite Creation Date:
2024-05-05 @ 11:56 PM
Last Modification Date:
2024-10-26 @ 10:42 AM
Study NCT ID:
NCT01456000
Status:
COMPLETED
Last Update Posted:
2016-09-08
First Post:
2011-10-17
Brief Title:
HeartLight Ablation in Patients With Paroxysmal Atrial Fibrillation PAF
Sponsor:
CardioFocus
Organization:
CardioFocus
Study Overview
Official Title:
Pivotal Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact EAS-AC or HEARTLIGHT for the Treatment of Symptomatic Atrial Fibrillation
Status:
COMPLETED
Status Verified Date:
2016-07
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:
HeartLight
Brief Summary:
The purpose of this study is to demonstrate the safety and effectiveness of the CardioFocus Endoscopic Ablation System with Adaptive Contact HeartLight in the treatment of atrial fibrillation by creating electrical isolation of the pulmonary veins
Detailed Description:
A randomized controlled trial designed to demonstrate the safety and effectiveness of the experimental device to deliver pulmonary vein isolation as a treatment for symptomatic atrial fibrillation
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