Atrial Fibrillation Clinical Trial
Official title:
The Contact-PVI Study - Does Assessment of Tissue Contact During RF Ablation Using the St. Jude Medical™ Ensite™ Contact™ System Increase Rates of Long-term Pulmonary Vein Isolation? A Prospective Randomised Study
This study aims to investigate the benefit of a new impedance-based computer software
application during routine catheter ablation for atrial fibrillation, to see if this
information improves short and long term electrical disconnection of the pulmonary veins.
This study will be a single blind prospective randomised control trial in patients undergoing
AF ablation. Study participants will be randomly assigned to undergo parts of their pulmonary
vein ablation with, and parts of their ablation without tissue contact data displayed for the
doctor performing the ablation to see. The pulmonary veins will then be studied at the end of
the procedure, and at any repeat procedure in the future, to look for a difference in the
recovery rate of the ablations performed using contact data, compared to those ablations
performed without the use of this contact data. If a reduction in tissue recovery is achieved
through the use of this tissue contact data, it may lead in the future to a reduced need for
repeat ablation procedures, and better outcomes for patients.
The investigators hypothesise that the use of the Ensite™ Contact™ ECI data will reduce the
recovery of conduction, and promote long-term pulmonary vein isolation in patients undergoing
left atrial ablation for atrial fibrillation.
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