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

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Rigshospitalet

Status

Completed

Conditions

Arrhythmia
Atrial Fibrillation

Treatments

Procedure: Catheter ablation (pulmonary vein isolation)

Study type

Interventional

Funder types

Other
Industry

Identifiers

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

  • 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)

Trial design

Primary purpose

Educational/Counseling/Training

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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