Viewing Study NCT00315068


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Study NCT ID: NCT00315068
Status: UNKNOWN
Last Update Posted: 2007-04-20
First Post: 2006-04-13
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Usefulness of Markers to Predict Recurrence of Atrial Fibrillation After Radiofrequency Catheter Ablation
Sponsor: University Hospital, Geneva
Organization:

Study Overview

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
Status: UNKNOWN
Status Verified Date: 2007-04
Last Known Status: ACTIVE_NOT_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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.
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 Oversight

Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: