Atrial Fibrillation Ablation and Autonomic Modulation Via Thorascopic Surgery
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims at investigating the role of autonomic modulation of AF. Therefore, totally
      thoracoscopic PV isolation with additional ablation of ganglionated plexi (GP) will be
      studied against PV isolation alone. Two groups of patients (paroxysmal AF with or without
      structural heart disease and persistent AF with or without heart disease) of 110 patients
      each will be studied.
    

Detailed description: 
      Atrial fibrillation (AF) is the most common chronic arrhythmia in man. Its treatment consists
      of control of ventricular rate or attempts to restore sinus rhythm. For symptomatic patients
      who fail on anti arrhythmic drugs, isolation of the pulmonary veins (PV), with additional
      linear left atrial lesions when appropriate, can cure AF. At least in some, but probably in
      many patients, the autonomous nervous system plays a pivotal role in the initiation and
      perpetuation of AF. The autonomic ganglia, or ganglionated plexi (GP) are located within the
      epicardial fat pads of the left atrium. This study aims at investigating the additional value
      of ablation of those GPs in addition to totally thoracoscopic PV isolation.

      Objective of the study:

      This study aims at investigating the role of autonomic modulation of AF. Therefore, totally
      thoracoscopic PV isolation with additional ablation of ganglionated plexi (GP) will be
      studied against PV isolation alone. Two groups of patients (paroxysmal AF with or without
      structural heart disease and persistent AF with or without heart disease) of 110 patients
      each will be studied.

      Study design:

      This is a single center, randomized single blinded study

      Study population:

      Any patient with an indication for non-pharmacological treatment of symptomatic paroxysmal or
      persistent AF can enter the study. An indication for non-pharmacological treatment exists
      when patients are symptomatic and have failed on at least one anti-arrhythmic drug. Symptoms
      of AF include, but are not limited to palpitations, reduced exercise capacity, exertional
      dyspnea, and fatigue. Failure of anti-arrhythmic therapy is defined as 1) recurrence of AF
      despite the use of an anti-arrhythmic drug in a clinical efficacious dosing or 2) adverse
      effects of medication that is not acceptable to the patient.

      Intervention (if applicable):

      In patients randomized to additional GP ablation, the following procedures will be carried
      out during the totally thoracoscopic procedure in addition to the PV isolation (and extended
      lesion set when appropriate): The left atrial autonomic GPs are localized within the
      epicardial fat pads and subsequently ablated with radiofrequency current delivered through an
      ablation probe (AtriCure Isolator™ Transpolar™ pen).
    

Intervention name(s): Totally Thoracoscopic PV isolation
Intervention type(s): Procedure
Intervention description(s): Surgery is performed through three ports bilaterally in the intercostal spaces. PVI is performed with a bipolar radiofrequency clamp and confirmed with a custom made multi-electrode probe with closely spaced (1mm) electrode terminals. Additional left atrial ablation lines are created and conduction block is verified in patients with persistent and permanent AF.
Other intervention name(s): Mini-Maze; VATS-PVI
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Atrial Fibrillation; Totally Thoracoscopic PV isolation