NCT00579098

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Atrial Fibrillation
• Arrhythmia
• Inflammation
• Endothelial Dysfunction

Interventions

Type	Name	Description
DRUG	Atorvastatin	80 mg tablet taken by mouth daily for 90 days
DRUG	Placebo	Placebo tablet taken by mouth once daily for 90 days

Timeline

• Start date: 2007-12-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2007-12-21
• Last updated: 2014-04-23
• Results posted: 2014-04-23

Locations

1 site across 1 country: United States