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The Use of Statins Following a Left Atrial Catheter Ablation Procedure to Prevent Atrial Fibrillation
This study is currently recruiting participants.
Study NCT00579098   Information provided by Mayo Clinic
First Received: December 18, 2007   Last Updated: August 4, 2009   History of Changes

December 18, 2007
August 4, 2009
December 2007
December 2009   (final data collection date for primary outcome measure)
Freedom from symptomatic atrial fibrillation at 3 months. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00579098 on ClinicalTrials.gov Archive Site
  • Freedom from atrial arrhythmia (as opposed to atrial fibrillation) recurrence irrespective of symptoms. [ Time Frame: 3 month ] [ Designated as safety issue: No ]
  • Reduction in CRP, lipid levels, and incidence of endothelial dysfunction at 3 months. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Improvement in quality of life. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Measurement of healthcare resource utilization and costs. [ Time Frame: 3 month ] [ Designated as safety issue: No ]
Same as current
 
The Use of Statins Following a Left Atrial Catheter Ablation Procedure to Prevent Atrial Fibrillation
Atorvastatin for Prevention of Atrial Fibrillation Recurrence Following Pulmonary Veins Isolation: A Double-Blind, Placebo-Controlled, Randomized Pilot Trial

To investigate whether statin therapy utilizing the drug Lipitor (atorvastatin) might be effective in preventing short-and long-term atrial fibrillation following a left atrial ablation procedure. We further hypothesize this reduction will result from diminished peri-procedural inflammation, which will be reflected in lower CRP values.

Although pharmacologic therapy is the traditional mainstay of therapy for AF, curative therapy has recently become possible.

There is growing evidence that inflammation may be involved in the pathogenesis of AF. C-reactive protein (CRP), a sensitive marker of systemic inflammation, is increased in patients with AF compared with patients in sinus rhythm. Elevated CRP levels are associated with increased likelihood of new onset AF and with recurrence of AF after successful cardioversion. Clinical and basic laboratory evidence suggests that, in addition to being potent lipid-lowering agents, statins may also have anti-inflammatory properties and protective effect against AF.

125 eligible patients with AF, undergoing left atrial ablation, will be randomly assigned in a 1:1 ratio to receive daily 80 mg of atorvastatin or placebo in a double-blind fashion for 3 months after their ablation procedure.

Patients will have baseline lipids, CRP, endothelial function tests (PAT)and Quality of Life (QoL) surveys compared with testing at 3 months post ablation.

Phase IV
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Efficacy Study
  • Atrial Fibrillation
  • Arrhythmia
  • Inflammation
  • Endothelial Dysfunction
  • Drug: Atorvistatin
  • Drug: Placebo
  • Active Comparator: Lipitor (atorvastatin),80 mg daily for 90 days
  • Placebo Comparator: Placebo once daily by mouth for 90 days.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
125
January 2010
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients > or = to 18 years of age
  • Clinically indicated left atrial ablation procedure for atrial fibrillation

Exclusion Criteria:

  • Exclusion criteria are known malignancy
  • Known inflammatory disease
  • Surgery or trauma or myocardial infarction in the previous month
  • Known contraindication to statin therapy
  • Elevated liver enzymes two times normal
  • Patients already receiving therapy with any statin, niacin or fibrates at the time of their randomization
Both
18 Years to 90 Years
No
Contact: Celeste M Koestler, RN 507-255-2200 koestler.celeste@mayo.edu
Contact: Diane M Batzel 507-538-7043 batzel.diane@mayo.edu
United States
 
NCT00579098
Dr. Paul Friedman, Mayo Clinic
07-005460
Mayo Clinic
Pfizer
Principal Investigator: Paul A Friedman, MD Mayo Clinic
Mayo Clinic
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP