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

This study has been completed.
Sponsor:
Collaborators:
Medtronic
Biosense Webster, Inc.
St. Jude Medical
Guidant Corporation
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00192972
First received: September 12, 2005
Last updated: December 21, 2005
Last verified: November 2003
  Purpose

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.


Condition Intervention
Atrial Fibrillation
Arrhythmia
Procedure: Catheter ablation (pulmonary vein isolation)

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

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • overall efficacy (= freedom from symptomatic, ECG documented AF or organized LA tachycardia (with a duration of > 10 min) without receiving antiarrhythmic medication)

Secondary Outcome Measures:
  • - safety
  • - resumption of LA-PV conduction
  • - neurohormones
  • - socio-economics (cost effectiveness)
  • - inflammatory markers
  • - quality of life
  • - signal averaged P wave signals-

Estimated Enrollment: 100
Study Start Date: November 2002
Estimated Study Completion Date: June 2005
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00192972

Locations
Denmark
Righospitalet, Copenhagen University Hospital
Copenhagen, Denmark, DK-2199
Sponsors and Collaborators
Rigshospitalet, Denmark
Medtronic
Biosense Webster, Inc.
St. Jude Medical
Guidant Corporation
Investigators
Principal Investigator: Brian Nilsson, MD Rigshospitalet, Denmark
Principal Investigator: Xu Chen, MD Righospitalet, Copenhagen, Denmark
Principal Investigator: Steen M Pehrson, MD Righospitalet, Copenhagen, Denmark
Principal Investigator: Lars Køber, MD Righospitalet, Copenhagen, Denmark
Principal Investigator: Jørgen Hilden, MD Department of biostatistics, University of Copenhagen
Principal Investigator: Jesper H Svendsen, MD Righospitalet, Copenhagen, Denmark
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00192972     History of Changes
Other Study ID Numbers: LASCAR
Study First Received: September 12, 2005
Last Updated: December 21, 2005
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Rigshospitalet, Denmark:
Catheter ablation
Atrial fibrillation

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Atrial Fibrillation
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 15, 2014