Catheter Ablation as the First Line Therapy for Typical Atrial Flutter

Catheter Ablation as the First Line Therapy for Symptomatic Typical Atrial Flutter: A Multicenter Randomized Study of Cost/Effectiveness

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00213408

Enrollment

120

Registered

2005-09-21

Start date

2001-06-30

Completion date

2007-01-31

Last updated

2013-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Flutter

Keywords

Arrhythmia, atrial flutter, catheter ablation

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 cost/effectiveness 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 questionnaires,12 leads ECG and 24-hour Holter monitoring are performed at 1, 3, 6 and 12 months following randomization.The 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 cost/effectiveness ratio of these two approaches.

Interventions

PROCEDURERadiofrequency catheter ablation of typical atrial flutter

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* first episode of symptomatic typical atrial flutter * \> 18 years old

Exclusion criteria

* Prior antiarrhythmic drug treatment for atrial flutter * History of cavotricuspid isthmus ablation * Pregnancy * Hyperthyroidism * contraindication for anticoagulant therapy * Life expectancy \< 1 year * contraindication to catheter ablation or to electrical cardioversion

Design outcomes

Primary

Measure	Time frame
Absence of typical atrial flutter recurrence at 6 and 12 months	—

Secondary

Measure	Time frame
Cost/effectiveness ratio at 12 months	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026