Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00231296
Status:
COMPLETED
Last Update Posted:
2017-05-04
First Post:
2005-09-30
Brief Title:
Safety and Efficacy of CryoCor Cryoablation for PAF
Sponsor:
Boston Scientific Corporation
Organization:
Boston Scientific Corporation
Study Overview
Official Title:
A Clinical Study to Evaluate the Safety and Efficacy of the CryoCorTMCardiac Cryoablation System for the Treatment of Paroxysmal Atrial Fibrillation
Status:
COMPLETED
Status Verified Date:
2017-05
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:
A multi-center randomized controlled study of cryoablation vs medical management for the treatment of PAF
Detailed Description:
The purpose of this prospective randomized multi-center clinical study is to establish the benefits of the CryoCorTM Cardiac Cryoablation System for treating symptomatic paroxysmal atrial fibrillation PAF in comparison to treatment with anti-arrhythmic medications alone This study also evaluates the safety profile of the CryoCorTM Cardiac Cryoablation System when used in this same setting
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None