Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00227344
Status:
TERMINATED
Last Update Posted:
2016-04-08
First Post:
2005-09-15
Brief Title:
CACAF2 Study Catheter Ablation for Cure of Atrial Fibrillation
Sponsor:
Biosense Webster EMEA
Organization:
Biosense Webster Inc
Study Overview
Official Title:
Catheter Ablation for Cure of Atrial Fibrillation
Status:
TERMINATED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study prematurely terminated due to randomization imbalance
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CACAF-2
Brief Summary:
The objective of this prospective multicenter randomized study is to establish the effectiveness of treatment of persistent atrial fibrillation by encircling the pulmonary veins with radiofrequency RF ablation and creating additional lines of block with the aid of the NAVISTAR THERMOCOOL catheter in conjunction with the CARTO EP Navigation System Effectiveness will be determined by comparing the chronic success of ablation therapy versus antiarrhythmic drug therapy defined as the absence of persistent tachyarrhythmias during the first 24 months after a run-in phase of 2 months
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