Atrial Fibrillation Management in Congestive Heart Failure With Ablation
Condition: Persistent Atrial Fibrillation; Heart Failure; ICD
MeSH terms: Heart Failure; Atrial Fibrillation
Study type: Interventional

Summary: 
      It is the purpose of the study to show the benefit of the endocardial catheter ablation by
      pulmonary vein isolation in patients with persistent or longstanding persistent atrial
      fibrillation, low LVEF and requiring ICD or CRT-D therapy compared to the best medical
      treatment with antiarrhythmic drugs.
    

Detailed description: 
      Atrial fibrillation is the most common sustained cardiac arrhythmia affecting 5% of people
      older than 65 years. It is associated with a 5 times increase of the risk of stroke in
      patients who are not receiving anticoagulant therapy and a doubling of the rate of death in
      all patients.

      Congestive heart failure (CHF) and atrial fibrillation (AF) often co-exist, where one
      condition is promoting the development of the other and worsens its condition.

      It is the purpose of the study to show the benefit of the endocardial catheter ablation by
      pulmonary vein isolation in patients with persistent (for a minimum of 1 week to a maximum of
      1 year duration) or longstanding persistent (for a minimum of 1 year to a maximum of 4 years)
      atrial fibrillation, low LVEF (<=35%) and requiring ICD or CRT-D therapy compared to the best
      medical treatment with antiarrhythmic drugs.

      Patients meeting the inclusion and exclusion criteria will be randomized in a 1:1 fashion in
      an unblinded, parallel arm treatment format to either drug therapy (directed at rate or
      rhythm control) or catheter ablation.

      All therapies will be established and optimized in a 3 month treatment initiation phase
      (Blanking Period) starting with randomization. For all morbidity and mortality end-points,
      intention-to-treat analysis will begin at randomization. Efficacy with respect to AF
      treatment will be established for long-term follow up beginning after 3-month initiation
      phase.

      Improvement of LVEF within 12 month is the primary endpoint of this study. The transthoracic
      echocardiographic (TTE) assessment at enrollment, discharge and 12 months follow-up follows a
      standardized protocol. The assessments are analyzed, calculated and expressed by an
      independent Core Lab.
    

Intervention name(s): ICD/CRT implant; AF ablation; Best Medical Treatment
Intervention type(s): Device; Procedure; Other
Intervention description(s): Implantation of a ICD/ CRT device if not yet implanted; Atrial Fibrillation ablation by pulmonary vein isolation; Best medical treatment according to current guidelines for Management of Patients with Atrial Fibrillation and for Management of Chronic Heart Failure.
Other intervention name(s): ICDs/ CRT-Ds: All St. Jude Medical device; RA, RV and LV leads: St. Jude Medical CE-marked leads recommended; Catheters: St. Jude Medical CE-marked catheters recommended; NavX system for 3D mapping; Conventional rate or rhythm control according valid guidelines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AF ablation; Pulmonary vein isolation(PVI); reduced LV ejection fraction; symptomatic atrial fibrillation; persistent AF