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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by University Hospital, Geneva.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT00315068
First received: April 13, 2006
Last updated: April 19, 2007
Last verified: April 2007
History of Changes
  Purpose

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
Atrial Fibrillation

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Geneva:
Estimated Enrollment: 180
Study Start Date: April 2004
Estimated Study Completion Date: August 2007
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.

  Eligibility
Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00315068

Locations
Switzerland
Cardiology Division University Hospital
Geneva, Switzerland, 1211
Sponsors and Collaborators
University Hospital, Geneva
Investigators
Principal Investigator: Pierre-Frederic Keller, MD Cardiology Division University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00315068     History of Changes
Other Study ID Numbers: PRD-03-I-03
Study First Received: April 13, 2006
Last Updated: April 19, 2007
Health Authority: Switzerland: Swissmedic

Keywords provided by University Hospital, Geneva:
arrythmia
atrial fibrillation
proteins

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

ClinicalTrials.gov processed this record on February 27, 2015