- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00315068
Usefulness of Markers to Predict Recurrence of Atrial Fibrillation After Radiofrequency Catheter Ablation
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
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.
Study Overview
Status
Conditions
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 Type
Enrollment
Contacts and Locations
Study Locations
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Geneva, Switzerland, 1211
- Cardiology Division University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Pierre-Frederic Keller, MD, Cardiology Division University Hospital
Study record dates
Study Major Dates
Study Start
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRD-03-I-03
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