A French Multi-centric Atrial Fibrillation Catheter Ablation Survey (FrenchAF)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University Hospital of Grenoble, Grenoble, France
Nouvelle Clinique Nantaise, Nantes, France
Parly 2 Medical Surgical Center (CMC), Le Chesnay, France
University Hospital of Rennes - Hospital Pontchaillou, Rennes, France
University Hospital of Rouen, Rouen, France
Information provided by (Responsible Party):
Serge Boveda, Clinique Pasteur
ClinicalTrials.gov Identifier:
NCT01918670
First received: August 6, 2013
Last updated: NA
Last verified: August 2013
History: No changes posted
  Purpose

Atrial fibrillation is the most frequent sustained arrhythmia. Catheter ablation is a procedure that is currently used for the treatment of symptomatic atrial fibrillation patients.

We have organized a multi-centric national survey of catheter ablation of atrial fibrillation in order to have a feedback on the type of procedures being performed and the overall results (freedom of atrial fibrillation) over an average follow-up of 18 months.


Condition Intervention
Observation of Outcome After Catheter Ablation of Atrial Fibrillation
Procedure: catheter ablation of atrial fibrillation

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 18 Months
Official Title: A French Multi-centric Atrial Fibrillation Catheter Ablation Survey

Resource links provided by NLM:


Further study details as provided by Clinique Pasteur:

Primary Outcome Measures:
  • Atrial fibrillation relapse [ Time Frame: starting 3 months after the procedure till an average of 18months follow-up ] [ Designated as safety issue: No ]
    Documentation of atrial fibrillation relapse (symptomatic or asymptomatic) after the first 3 months after the index procedure


Secondary Outcome Measures:
  • Early atrial fibrillation relapse [ Time Frame: first 3 months ] [ Designated as safety issue: No ]
    Documented atrial fibrillation relapse (symptomatic or asymptomatic) in the first 3 months after the index procedure


Study Start Date: November 2010
Estimated Study Completion Date: December 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Pasteur Procedure: catheter ablation of atrial fibrillation
electric pulmonary vein disconnection
Grenoble Procedure: catheter ablation of atrial fibrillation
electric pulmonary vein disconnection
Nantes Procedure: catheter ablation of atrial fibrillation
electric pulmonary vein disconnection
Parly Procedure: catheter ablation of atrial fibrillation
electric pulmonary vein disconnection
Rennes Procedure: catheter ablation of atrial fibrillation
electric pulmonary vein disconnection
Rouen Procedure: catheter ablation of atrial fibrillation
electric pulmonary vein disconnection

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients undergoing catheter ablation in one of the registry centers

Criteria

Inclusion Criteria:

  • all patients undergoing catheter ablation of atrial fibrillation or left atrial flutter

Exclusion Criteria:

  • patients undergoing catheter ablation of other types of arrhythmia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01918670

Locations
France
Clinique Pasteur
Toulouse, France
Sponsors and Collaborators
Clinique Pasteur
University Hospital of Grenoble, Grenoble, France
Nouvelle Clinique Nantaise, Nantes, France
Parly 2 Medical Surgical Center (CMC), Le Chesnay, France
University Hospital of Rennes - Hospital Pontchaillou, Rennes, France
University Hospital of Rouen, Rouen, France
  More Information

No publications provided

Responsible Party: Serge Boveda, MD, Clinique Pasteur
ClinicalTrials.gov Identifier: NCT01918670     History of Changes
Other Study ID Numbers: FrenchAFAblationSurvey
Study First Received: August 6, 2013
Last Updated: August 6, 2013
Health Authority: France: no authority.

Keywords provided by Clinique Pasteur:
atrial fibrillation; catheter ablation; relapse; stroke; death

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

ClinicalTrials.gov processed this record on April 15, 2014