Comparison Between Contact Force Guided and Blinded Strategy on PV Isolation in AF Patients
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      Pulmonary vein (PV) isolation is very important in atrial fibrillation (AF) catheter
      ablation. PV reconnection is one of the main reasons in AF recurrence. Contact force-sensing
      catheter is a new catheter which has valuable tools to monitor and increase the efficacy of
      PV isolation. Previous paper reported the efficacy of contact force-sensing catheter on
      immediate PV isolation and outcome. However, there might be confounding factor as
      inter-individual variation. Therefore, we would like to compare the efficacy of contact
      force-sensing catheter within same patient but different veins.

      In this study, we would like to confirm the efficacy of contact force-sensing catheter on
      immediate PV isolation outcome within same patient. This study randomized the right or left
      PVs whether to use the contact force-sensing function or not. The study design will minimize
      the inter-individual variation on evaluating the efficacy of contact force-sensing catheter
      on immediate PV isolation.

      Also, in patients who had recurred AF or AT, we would like to evaluate the long-term efficacy
      of contact force-sensing catheter on PV isolation.
    

Detailed description: 
      Sixty patients will be randomized to select right or left pulmonary veins whether to apply
      contact force-guided ablation or contact force-blinded ablation strategy. Each PV will be
      ablated with same contact force-sensing catheter (Thermocool Smart Touch Catheter, Biosense
      Webster Inc. CA). The PV (right or left) which will be randomized to contact force-sensing PV
      or blind PV. Contact force-sensing PV will be ablated guided by contact force, whereas the
      blind PVs will be ablated without contact force-sensing information. The change of impedance,
      total ablation and time to ablate PV will be collected and analysed according to contact
      force-sensing strategy. After exit and entrance block by conventional method, dormant
      conduction will be evaluated by using adenosine. The proportion of dormant conduction will be
      compared between contact force-sensing guided or blinded strategy.

      During 1-year follow up, patients who recurred AF or AT will be undergo second ablation
      procedure. In these patients, PV reconnection rate will be evaluated by a duodecapolar lasso
      circular mapping catheter. We would like to know whether PVs which have ablated with contact
      force-sensing information at index procedure have less reconnection than those which was
      ablated without contact force-sensing information.
    

Intervention name(s): SmartTouch Catheter
Intervention type(s): Device
Intervention description(s): Pulmonary vein (PV) isolation guided by CF information
Other intervention name(s): Contact force guided pulmonary vein isolation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pulmonary vein isolation; contact force sensing catheter