A Randomized Trial of the Ostial Versus the Extra-Ostial Ablation Strategy for Atrial Fibrillation

Study Overview
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Brief Summary
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Both segmental, ostial and circumferential, extra-ostial pulmonary vein (PV) isolation have been proven effective in the treatment of atrial fibrillation. In this study patients with symptomatic paroxystic or persistent AF were randomised to one of the above mentioned ablation methods. The primary endpoints were recurrent AF and recurrence of left atrium-PV conduction.

Detailed Description
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Both segmental, ostial and circumferential, extra-ostial pulmonary vein (PV) isolation have been proven effective in the treatment of atrial fibrillation. In this study with symptomativ paroxystic or persistent AF were randomised to one of the above mentioned ablation methods. Each patient was allowed a maximum of two ablation procedures. Holter monitoring for 14-days periods will be performed at 3 months after ablation. The patiens are seen at out-patient visits at 1, 3, 6, 9, and 12 months after the ablation procedure. Primary endpoints were recurrent AF and recurrence of left atrium-PV conduction. Secondary endpoints were: safety resumption of LA-PV conduction alterations in neurohormones socio-economics aspects(cost effectiveness) changes in inflammatory markers quality of life alterations in signal averaged P wawe signals evaluation of the predictive value of these variables to predict recurrence of AF

Official Title
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A Randomized Trial of the Ostial Versus the Extra-Ostial Ablation Strategy for Atrial Fibrillation (LASso Vs CARto)

Conditions
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Atrial Fibrillation, Arrhythmia

Intervention / Treatment
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* Procedure: Catheter ablation (pulmonary vein isolation)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: symptomatic paroxysmal or persistent AF for more than 6 months, with at least 3 episodes in 3 months and with insufficient effect of at least 2 pharmacological regimens Exclusion Criteria: congenital heart disease age under 18 years significant valve disease left atrial size > 55 mm prior ablation for AF Severe heart failure (LVEF < 20 % and/or NYHA class IV)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Educational/Counseling/Training
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Catheter ablation (pulmonary vein isolation)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall efficacy (= freedom from symptomatic, ECG documented AF or organized LA tachycardia (with a duration of > 10 min) without receiving antiarrhythmic medication) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - safety |  |  | 
| - resumption of LA-PV conduction |  |  | 
| - neurohormones |  |  | 
| - socio-economics (cost effectiveness) |  |  | 
| - inflammatory markers |  |  | 
| - quality of life |  |  | 
| - signal averaged P wave signals- |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Catheter ablation, Atrial fibrillation