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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00192972 |
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Date of registration:
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12/09/2005 |
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Primary sponsor: |
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Public title:
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A Randomized Trial of the Ostial Versus the Extra-Ostial Ablation Strategy for Atrial Fibrillation
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Scientific title:
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A Randomized Trial of the Ostial Versus the Extra-Ostial Ablation Strategy for Atrial Fibrillation (LASso Vs CARto) |
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Date of first enrolment:
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November 2002 |
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Target sample size:
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100 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00192972 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Jørgen Hilden, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of biostatistics, University of Copenhagen |
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Name:
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Jesper H Svendsen, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Righospitalet, Copenhagen, Denmark |
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Name:
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Lars Køber, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Righospitalet, Copenhagen, Denmark |
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Name:
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Steen M Pehrson, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Righospitalet, Copenhagen, Denmark |
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Name:
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Xu Chen, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Righospitalet, Copenhagen, Denmark |
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Name:
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Brian Nilsson, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Rigshospitalet Copenhagen Denmark |
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Key inclusion & exclusion criteria
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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)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Arrhythmia
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Atrial Fibrillation
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Intervention(s)
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Procedure: Catheter ablation (pulmonary vein isolation)
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Primary Outcome(s)
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overall efficacy (= freedom from symptomatic, ECG documented AF or organized LA tachycardia (with a duration of > 10 min) without receiving antiarrhythmic medication)
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Secondary Outcome(s)
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- inflammatory markers
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- neurohormones
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- quality of life
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- resumption of LA-PV conduction
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- safety
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- signal averaged P wave signals-
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- socio-economics (cost effectiveness)
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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