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

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Mayo Clinic

Status and phase

Completed
Phase 4

Conditions

Inflammation
Arrhythmia
Atrial Fibrillation
Endothelial Dysfunction

Treatments

Drug: Atorvastatin
Drug: Placebo

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00579098
07-005460

Details and patient eligibility

About

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.

Full 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.

Enrollment

125 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

125 participants in 2 patient groups, including a placebo group

Atorvastatin
Active Comparator group
Description:
Lipitor (atorvastatin) 80 mg tablet taken once daily by mouth for 90 days
Treatment:
Drug: Atorvastatin
Placebo
Placebo Comparator group
Description:
Placebo (dummy) tablet taken once daily by mouth for 90 days
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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