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Usefulness of Markers to Predict Recurrence of Atrial Fibrillation After Radiofrequency Catheter Ablation

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ClinicalTrials.gov Identifier: NCT00315068
Recruitment Status : Unknown
Verified April 2007 by University Hospital, Geneva.
Recruitment status was:  Active, not recruiting
First Posted : April 17, 2006
Last Update Posted : April 20, 2007
Sponsor:
Information provided by:
University Hospital, Geneva

Study Description
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Brief Summary:

Catheter ablation using radiofrequency is a new therapeutic tool to treat atrial fibrillation with a higher success rate than medical therapy (80% versus less than 50% respectively). Because of the length of the intervention and of the risk of complications of the procedure, it would be important to determine success rate before the intervention. The information gained from this study will in all probability improve our estimation of the chances of a successful intervention and may enable us to take necessary therapeutic measures in case of an elevated risk of recurrence.

Multiple studies suggest that the 2 markers in this study could provide information of this nature, however, their utility in the radiofrequency catheter ablation treatment of atrial fibrillation has never been demonstrated.


Condition or disease
Atrial Fibrillation

Detailed Description:

Catheter ablation of atrial fibrillation is a recent therapeutic tool to treat atrial fibrillation. The success rate of eliminating atrial fibrillation by radiofrequency catheter ablation is 80 %, after one or sometimes two procedures, against 20-50 % with drug treatment.

This intervention may be complicated by : hematoma at the puncture site - 1 % incidence; thromboembolic events < 1 % incidence; cardiac perforation with tamponade < 1 %, pulmonary vein stenosis 2 % incidence.

The aim of this study is to evaluate blood tests of biological products (NT-proBNP and CRP) as markers of prognosis and success after radiofrequency catheter ablation for atrial fibrillation.

Previous studies demonstrated the prognostic value of NT-proBNP and CRP in the recurrence of atrial fibrillation after electrical cardioversion. However the prognostic value of these biomarkers was never demonstrated in the setting of radiofrequency catheter ablation of atrial fibrillation.

This is an observation study including 180 patients with the indication of catheter ablation for atrial fibrillation. Confounding factors of increased NT-proBNP will be assessed with echocardiographic imaging.

Study Design
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Study Type : Observational
Enrollment : 180 participants
Observational Model: Defined Population
Time Perspective: Prospective
Official Title: The Value of Amino-Terminal Brain Natriuretic Peptide and C-Reactive Protein Serum Levels for Predicting Recurrence of Atrial Fibrillation and/or Atrial Flutter After Radiofrequency Catheter Ablation
Study Start Date : April 2004
Estimated Study Completion Date : August 2007

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Groups and Cohorts
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • atrial fibrillation
  • indication for catheter ablation of atrial fibrillation

Exclusion Criteria:

  • significant valvulopathy
  • previous catheter ablation for atrial fibrillation or atrial flutter
  • left ventricular ejection fraction < 30%
  • Severe heart failure (NYHA IV)
  • Severe enlargement of left atrium (> 55mm)
Contacts and Locations
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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): NCT00315068


Locations
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Switzerland
Cardiology Division University Hospital
Geneva, Switzerland, 1211
Sponsors and Collaborators
University Hospital, Geneva
Investigators
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Principal Investigator: Pierre-Frederic Keller, MD Cardiology Division University Hospital
More Information
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ClinicalTrials.gov Identifier: NCT00315068    
Other Study ID Numbers: PRD-03-I-03
First Posted: April 17, 2006    Key Record Dates
Last Update Posted: April 20, 2007
Last Verified: April 2007
Keywords provided by University Hospital, Geneva:
arrythmia
atrial fibrillation
proteins
Additional relevant MeSH terms:
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Atrial Fibrillation
Recurrence
Arrhythmias, Cardiac
Heart Diseases
 Cardiovascular Diseases
Pathologic Processes
Disease Attributes