Computed Tomography Targets for Efficient Guidance of Catheter Ablation in Ventricular Tachycardia (MAP-IN-HEART)
Condition: Ventricular Tachycardia
MeSH terms: Tachycardia; Tachycardia, Ventricular
Study type: Interventional

Summary: 
      The hypothesis of MAP IN HEART is that catheter ablation for post-infarction ventricular
      tachycardia (VT) can be largely improved through a direct definition of primary ablation
      targets from pre-operative CT scan imaging. The objective of is to demonstrate that catheter
      ablation of post-infarction VT targeting left ventricular wall thickness channels as defined
      from CT scan is feasible and associated with favorable efficacy, efficiency and safety
      profiles. A single-arm prospective cohort study will be conducted, including 40 patients over
      3 European centres. Baseline, procedural and 6-month follow-up data will be analyzed
    

Detailed description: 
      Background: Although catheter ablation is a recommended therapeutic option in patients with
      history of myocardial infarction presenting with sustained ventricular tachycardia (VT),1 the
      current approach relies on lengthy, poorly reproducible and poorly standardized
      identification of targets derived from invasive catheter measurements. As a consequence, the
      rate of VT recurrence remains high, leading to repeat interventions.2 Pre-operative CT scan
      imaging was shown able to identify arrhythmogenic sites within scar through a detailed
      analysis of left ventricular (LV) wall thickness.3,4 This study aims at demonstrating that
      using these as primary targets for ablation is a feasible strategy associated with favorable
      efficacy, efficiency and safety profiles.

      Methods: 40 patients with post-infarction VT referred for catheter ablation will be included
      over 3 European centres. Pre-operative CT scan will be processed to obtain a 3D model of the
      patient heart comprising detailed anatomy and LV wall thickness maps. Channels of relatively
      preserved thickness penetrating within severely thinned scar (i.e. CT-channels) will be
      identified using a proprietary algorithm developed at the IHU LIRYC, University of Bordeaux,
      and used as primary targets for catheter ablation. During the intervention, the 3D model
      along with pre-operatively defined targets will be registered in the 3D mapping space, and
      each CT-channel will be transected by ablation. The inducibility of VT will then be tested
      and any VT remaining inducible after CT-channels ablation will be targeted using conventional
      catheter mapping techniques, with a composite procedural endpoint combining the ablation of
      all CT channels and the non-inducibility of any VT. Procedural and 6-month follow-up data
      will be analyzed to assess the feasibility of the approach and report its efficiency,
      efficacy and safety profiles.

      Expected results: the CT-guided ablation strategy is expected to be feasible in a vast
      majority of post-infarction patients referred for VT ablation, and to be extremely
      time-efficient, the lengthy diagnostic part of the procedure (catheter mapping) being moved
      pre-operatively (imaging). The short procedure duration should translate into a favorable
      safety profile. The strategy should also be associated with a high efficacy in eliminating
      the arrhythmia, thanks to a more comprehensive definition of targets and to the dedication of
      the procedure time almost entirely to therapy. In conclusion, the present study should
      provide solid proof of concept on which randomized controlled trials may be built.
    

Intervention name(s): Catheter ablation procedure with heart 3D model
Intervention type(s): Device
Intervention description(s): Device: Catheter ablation procedure performed as part of standard care, although with the addition of an image-based 3D heart model including detailed anatomy and primary ablation targets
Intervention model: Single Group Assignment
Intervention model description: Catheter ablation procedure performed as part of standard care, although with the addition of an image-based 3D heart model including detailed anatomy and primary ablation targets
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Myocardial infarction; Ventricular Tachycardia; Catheter Ablation; Imaging; Cardiac computed tomography