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

Rigshospitalet

Status

Completed

Conditions

Arrhythmia

Atrial Fibrillation

Treatments

Procedure: Catheter ablation (pulmonary vein isolation)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00192972

LASCAR

Details and patient eligibility

About

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.

Full 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

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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