First Line Radiofrequency Ablation Versus Antiarrhythmic Drugs for Atrial Fibrillation Treatment (The RAAFT Study)
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether catheter-based pulmonary vein isolation is
      superior to antiarrhythmic drugs as first line therapy in patients with symptomatic
      paroxysmal recurrent atrial fibrillation not previously treated with therapeutic doses of
      antiarrhythmic drugs.
    

Detailed description: 
      Atrial fibrillation (AF) is the most common arrhythmia encountered in clinical practice and
      is estimated to affect 2.2 million people in the United States. AF is a major cause of
      stroke, adversely affects quality of life, and is associated with increased mortality.
      Despite advances in antiarrhythmic drug therapy, AF continues to be associated with
      significant morbidity. Although antiarrhythmic drug therapy is currently considered a
      first-line option, recent data indicate that more than 35% of Patients will have recurrence
      of AF despite best antiarrhythmic drug (AAD) therapy, and more than 30% of Patients will
      discontinue the drugs because of adverse reactions. Furthermore, although recent trials have
      indicated equivalence of rhythm and rate control strategies in some patient populations,
      25-35% of Patients with AF who are rate controlled will continue to have activity limiting
      symptoms. Newer measures to prevent, treat and potentially cure AF are needed. Seminal work
      by Haissaguerre and replicated by Chen showed that the majority of AF is initiated by ectopic
      foci found primarily in the pulmonary veins (PV). Experience with the catheter-based Maze
      technique led to observations that opened the door to effective and practical catheter-based
      cures for AF. In response to the difficulties of focal ablation, an alternate strategy has
      been developed that seeks to electrically isolate the Pulmonary Veins from the atrial tissue.
      Empirical PV isolation targets all of the PV's without regard to the initiation of ectopic
      beats. The goal is to create entrance block in the PV. Multipolar circular catheters and
      basket catheters have been developed that facilitate identification of the electrical
      connections that are present at the junction of the atrium and the PV, and radiofrequency
      energy is applied in a circumferential fashion until entrance block is achieved. Relative to
      focal ablation, circumferential PV isolation is simpler to perform, can be completed without
      inducing AF, has a shorter procedure time, and has a lower incidence of PV stenosis.

      Comparison: Patients will have ablation to achieve entrance and/or exit block into all
      pulmonary veins, compared with patients receiving antiarrhythmic drugs given in accordance
      with ACC/AHA/ESC 2006 Guidelines for the Management of patients with AF.
    

Intervention name(s): Pulmonary Vein Isolation performed by Catheter Ablation; Conventional Antiarrhythmic Drug Therapy
Intervention type(s): Procedure; Drug
Intervention description(s): Ablation will be done to achieve entrance block into all pulmonary veins.; Anti-Arrhythmic Drugs per ACC/AHA 2006 Guidelines for the Management of Patients with AF
Intervention MeSH terms: Anti-Arrhythmia Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Atrial Fibrillation; Paroxysmal; Pulmonary Vein Isolation; Ablation Catheter; Anti-arrhythmic Drug Therapy; First Line Therapy