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

NCT01183091 | Completed

• 1 other identifier: P040411
• Study Type: observational
• Target: 503
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation; Ablation

Outcome Measures

Primary Outcomes (1)

• Success of ablation

  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.

  after 3 months

Study Arms (1)

First AF ablation

Description of the patients experiencing an AF ablation

Procedure: Ablation of atrial fibrillation

Interventions

Ablation of atrial fibrillation PROCEDURE

Ablation of atrial fibrillation

First AF ablation

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Description of the patients experiencing a first AF ablation

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

Service de cardiologie - Hôpital Lariboisière

Paris, 75010, France

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Antoine LEENHARDT, MD,PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2010
• First Posted: August 17, 2010
• Study Start: April 1, 2005
• Primary Completion: July 1, 2008
• Study Completion: October 1, 2010
• Last Updated: September 20, 2012

Record last verified: 2012-09

Locations

FR (1)