Paroxysmal Atrial Fibrillation Clinical Trial
Official title:
The Canadian Atrial Fibrillation Force Contact Ablation Study
This study will be divided into two phases. The purpose of the Phase I registry is to assess
the current force being used for ablation of symptomatic paroxysmal AF in a wide range of
operators in different Canadian centres with the operators being blinded to the contact force
data.
In Phase II of the study, operators will have open use of the force contact data. Phase I and
II data will be compared in order to assess the efficiency of using the THERMOCOOL®
SMARTTOUCH™ catheter.
Atrial fibrillation (AF) is the most common arrhythmia affecting over 5% of the population
above the age of 65 years. The use of percutaneous catheter ablation for symptomatic
management has increased over the last decade. It is well established that AF ablation is
superior to anti-arrhythmic drugs for symptomatic recurrence of AF. Despite this, success
rates with a single procedure for paroxysmal AF is approximately 80% with the majority of
recurrence due to recovery of lesions or "gaps" found at repeat procedures.
In this study, patients with symptomatic paroxysmal atrial fibrillation (AF) will undergo
ablation using a newly Health Canada approved catheter with SmartTouch technology that
enables the measurement of catheter tip contact force and direction inside the heart. The
purpose of Phase I of the study is to assess the current force being used for ablation of
symptomatic paroxysmal AF in a wide range of operators in different Canadian centres with the
operators being blinded to the contact force data.
The secondary objective will be to assess whether lesion recovery, as assessed in redo
procedures, corresponds to contact force measurements. It is hypothesized that gaps found on
repeat procedures will correspond to ablation lesions associated with a lower contact force.
In Phase II, operators will have open use of the force contact data. Phase I and II data will
be compared in order to assess the efficiency of using the SmartTouch catheter. It is
hypothesized that the open use of contact force data will decrease the procedural time and
number of lesions to achieve bidirectional pulmonary vein isolation.
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