Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00477230
Status:
TERMINATED
Last Update Posted:
2012-06-27
First Post:
2007-05-21
Brief Title:
Pivotal Clinical Study of Endoscopic Ablation for Atrial Fibrillation AF in Patients That Have Failed Drugs
Sponsor:
CardioFocus
Organization:
CardioFocus
Study Overview
Official Title:
Pivotal Clinical Study of the CardioFocus Endoscopic Ablation System for the Treatment of Symptomatic Atrial Fibrillation AF
Status:
TERMINATED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study terminated based on decision of Sponsor
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENABLE
Brief Summary:
The purpose of the study is to compare two types of treatment for atrial fibrillation AF that are designed to treat the symptoms of atrial fibrillation The treatments being compared are
A single catheter ablation procedure with the investigational EAS a visually-guided light-energy catheter
Standard drug therapy antiarrhythmic drugs
To learn more about the CardioFocus ENABLE investigational clinical study please contact the study site closest to you
Eligibility Criteria
Persons with paroxysmal atrial fibrillation may be eligible for this study Other study eligibility criteria include
18 to 80 years of age
Frequent episodes of AF
Failed at least 1 drug treatment for AF beta-blockers or standard AADs
Other criteria
A single catheter ablation procedure with the investigational EAS a visually-guided light-energy catheter
Standard drug therapy antiarrhythmic drugs
To learn more about the CardioFocus ENABLE investigational clinical study please contact the study site closest to you
Eligibility Criteria
Persons with paroxysmal atrial fibrillation may be eligible for this study Other study eligibility criteria include
18 to 80 years of age
Frequent episodes of AF
Failed at least 1 drug treatment for AF beta-blockers or standard AADs
Other criteria
Detailed Description:
None
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