Atrial Fibrillation Clinical Trial
Official title:
A Randomized Trial of the Ostial Versus the Extra-Ostial Ablation Strategy for Atrial Fibrillation (LASso Vs CARto)
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.
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
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training
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