The Use of Statins Following a Left Atrial Catheter Ablation Procedure to Prevent Atrial Fibrillation

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

Detailed Description
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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. 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 and Quality of Life (QoL) surveys compared with testing at 3 months post ablation.

Official Title
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Atorvastatin for Prevention of Atrial Fibrillation Recurrence Following Pulmonary Veins Isolation: A Double-Blind, Placebo-Controlled, Randomized Pilot Trial

Conditions
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Atrial Fibrillation, Arrhythmia, Inflammation, Endothelial Dysfunction

Intervention / Treatment
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* Drug: Atorvastatin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients > or = to 18 years of age Clinically indicated left atrial ablation procedure for atrial fibrillation Exclusion Criteria: Known malignancy Known inflammatory disease Surgery or trauma or myocardial infarction in the previous month Known contraindication to statin therapy Elevated liver enzymes above two times the upper limit of normal Patients already receiving therapy with any statin, niacin or fibrates at the time of their randomization

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Atorvastatin<br>Lipitor (atorvastatin) 80 mg tablet taken once daily by mouth for 90 days | Drug: Atorvastatin<br>* 80 mg tablet taken by mouth daily for 90 days<br>* Other names: Lipitor;|
| Placebo Comparator: Placebo<br>Placebo (dummy) tablet taken once daily by mouth for 90 days | Drug: Placebo<br>* Placebo tablet taken by mouth once daily for 90 days<br>* Other names: Placebo (dummy) tablet to match appearance of atorvastatin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects Without Symptoms of Atrial Fibrillation at 3 Months | Asymptomatic recurrence was defined as any atrial arrhythmia lasting more than 30 seconds. This was assessed by an electrocardiogram (ECG) and 72-hour Holter monitor recordings. At the end of the study, 336 ECG and Holter recordings were available for analysis (172 in the atorvastatin group and 164 in the placebo group). | Baseline through 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects Without Atrial Arrhythmia at 3 Months | Percentage of subjects without atrial arrhythmia (as opposed to atrial fibrillation) recurrence, irrespective of symptoms. Atrial arrhythmias included AF, atrial tachycardia and atrial flutter. | Baseline through 3 months | 
| Change in Mean C-Reactive Protein Level |  | Baseline and 3 months | 
| Change in Mean Quality of Life Score | A visual analogue scale (VAS) was used to collect the subject's perception of their current state of health/quality of life. The VAS consists of a vertical 20 centimeter scored line (like a thermometer) with the ends labelled best imaginable health state at the top (100) and worst imaginable health state at the bottom (0). The subject marked a single line to grade his/her own current level of function at the baseline visit and again at the 3 month visit. The average change in VAS score from baseline to 3 months later is reported for each treatment group. | Baseline and 3 months | 
| Change in Lipid Levels | The change from baseline to 3 months in blood cholesterol levels (total cholesterol, LDL or low-density lipoprotein and HDL or high-density lipoprotein) was calculated. | Baseline and 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial Fibrillation, Arrhythmia, Pulmonary Vein Isolation, Left atrial catheter ablation, Inflammation, Endothelial dysfunction