Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00213408
Status:
TERMINATED
Last Update Posted:
2013-06-18
First Post:
2005-09-13
Brief Title:
Catheter Ablation as the First Line Therapy for Typical Atrial Flutter
Sponsor:
University Hospital Rouen
Organization:
University Hospital Rouen
Study Overview
Official Title:
Catheter Ablation as the First Line Therapy for Symptomatic Typical Atrial Flutter A Multicenter Randomized Study of CostEffectiveness
Status:
TERMINATED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
end of the follow-up period
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Catheter ablation of typical atrial flutter is a well established technique with a high acute success rate and very low complication and recurrence rates It has also been shown that ablation of recurrent symptomatic typical atrial flutter led to a clear improvement in quality of life We sought to evaluate the costeffectiveness of catheter ablation as the first line therapy in patient suffering from their first symptomatic typical atrial flutter episode This study is a multicenter trial in which patients with a first symptomatic episode of typical atrial flutter are randomized to undergo ablation or to receive antiarrhythmic drugs after electrical cardioversion Clinical examination quality of life questionnaires12 leads ECG and 24-hour Holter monitoring are performed at 1 3 6 and 12 months following randomizationThe primary end-point is the absence of recurrence of typical atrial flutter at - and 12 months of follow up The secondary end points are the cost and the costeffectiveness ratio of these two approaches
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