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

This study has been completed.
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01183091
First received: August 16, 2010
Last updated: September 19, 2012
Last verified: September 2012
History of Changes
  Purpose

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 Intervention
Atrial Fibrillation
 Procedure: Ablation of atrial fibrillation

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Success of ablation [ Time Frame: after 3 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 503
Study Start Date: April 2005
Study Completion Date: October 2010
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
First AF ablation
Description of the patients experiencing an AF ablation
 Procedure: Ablation of atrial fibrillation
Ablation of atrial fibrillation

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01183091     History of Changes
Other Study ID Numbers: P040411
Study First Received: August 16, 2010
Last Updated: September 19, 2012
Health Authority: France: Ministry of Health

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

ClinicalTrials.gov processed this record on October 17, 2012