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Completed

NCT Number: NCT00192972

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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmia Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Righospitalet, Copenhagen University Hospital

Copenhagen, DK-2199, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Catheter ablation (pulmonary vein isolation)

Procedure

Primary outcomes

  1. overall efficacy (= freedom from symptomatic, ECG documented AF or organized LA tachycardia (with a duration of > 10 min) without receiving antiarrhythmic medication)

Secondary outcomes

  1. - safety

  2. - resumption of LA-PV conduction

  3. - neurohormones

  4. - socio-economics (cost effectiveness)

  5. - inflammatory markers

  6. - quality of life

  7. - signal averaged P wave signals-

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Abbott Medical Devices
  • Biosense Webster, Inc.
  • Guidant Corporation
  • Medtronic

Registry information

Official study title

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

Important dates

Study start
2002
Study completion
2005
First posted
Sep 19, 2005
Registry last updated
Dec 22, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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