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Medical Economical Evaluation of the Ablation by Catheter of the Atrial Tissue in the Treatment of AF (EVABLAF)

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ClinicalTrials.gov Identifier: NCT01183091
Recruitment Status : Completed
First Posted : August 17, 2010
Last Update Posted : September 20, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The atrial fibrillation is the most frequent confusions of the heart rhythm: his preValencia increases with the age, and the investigators consider that beyond 65 years, 5 % of the population is affected by this arrhythmia. It entails a greater risk of morbidity (thromboembolic accident and cardiac insufficiency) and of cardiovascular mortality (mortality increased by a factor 1,7 - 2) independents of the causal pathology or the associated risk factors. For all these reasons, it raises a real problem of public health.

Condition or disease Intervention/treatment
Atrial Fibrillation Procedure: Ablation of atrial fibrillation

  Show Detailed Description

Study Design

Study Type : Observational
Actual Enrollment : 503 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Medical Economical Evaluation of the Ablation by Catheter of the Atrial Tissue in the Treatment of the Atrial Fibrillation
Study Start Date : April 2005
Primary Completion Date : July 2008
Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
First AF ablation
Description of the patients experiencing an AF ablation
Procedure: Ablation of atrial fibrillation
Ablation of atrial fibrillation


Outcome Measures

Primary Outcome Measures :
  1. Success of ablation [ Time Frame: after 3 months ]
    The principal criterion of the medical evaluation is the success of ablation defined by the absence of repetition of AF (or the persistence of the sinusal rhythm) after the 3 months period following the procedures of ablation based on ECG or holter registration. These patients are likely to be able to profit from another procedure of ablation so necessary.


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Description of the patients experiencing a first AF ablation
Criteria

Inclusion Criteria:

  • Nonspontaneous and ≤90 days) symptomatic and dating of more than 6 months
  • Patient in failure of at least 1 antiarrythmic major (Class Ic or amiodarone) or repeats after at least 1 medicamentous or electric reduction
  • Patient having presented at least 1 episode of F documented by ECG or Holter
  • Patient having a medical history of AF which can be reconstituted retrospectively over the last 12 months
  • Patient currently under anticoagulant treatment by AVK balanced

Exclusion Criteria:

  • Patient presenting asymptomatic AF
  • Patient presenting AF permanent (90 days)
  • Patient presenting a counter-indication at the anticoagulants by oral way
  • Patient presenting of the antecedents of ablation of AF
  • Patient presenting an intracardiac thrombus
  • Patient presenting reversible AF of cause
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01183091


Locations
France
Service de cardiologie - Hôpital Lariboisière
Paris, France, 75010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: Antoine LEENHARDT, MD,PhD Assistance Publique - Hôpitaux de Paris
More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01183091     History of Changes
Other Study ID Numbers: P040411
First Posted: August 17, 2010    Key Record Dates
Last Update Posted: September 20, 2012
Last Verified: September 2012

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Atrial fibrillation
Ablation

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