Atrial Fibrillation Clinical Trial
Official title:
Comparison of Acute Pulmonary Vein (PV) Reconnection Between Contact Force Guided and Blinded PV Isolation in Patients With Symptomatic Atrial Fibrillation
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.
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.
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