Arrhythmia, Atrial Fibrillation
Conditions
Keywords
Catheter ablation, Atrial fibrillation
Brief summary
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
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
Interventions
PROCEDURECatheter ablation (pulmonary vein isolation)
Sponsors
Medtronic
Biosense Webster, Inc.
Abbott Medical Devices
Guidant Corporation
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
ECT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| - resumption of LA-PV conduction | — |
| - neurohormones | — |
| - socio-economics (cost effectiveness) | — |
| - safety | — |
| - quality of life | — |
| - signal averaged P wave signals- | — |
| - inflammatory markers | — |
Countries
Denmark
Outcome results
None listed