Atrial Fibrillation Clinical Trial
Official title:
A Prospective Safety, Performance and Preliminary Effectiveness, Multi-centre, Clinical Investigation Using the Irrigated TactiCath™ Percutaneous Ablation Catheter for the Treatment of Supra-Ventricular Tachyarrhythmia Using RF Ablation
The main objective of this study is to demonstrate the clinical safety of a contact force sensing RF ablation catheter when used for the treatment of supraventricular tachycardia and atrial fibrillation. In addition, the study will characterize the use and value of contact force measurement during ablation, and the long term success (12 months) of the ablation procedure using this technology.
Safety: The primary safety endpoint assesses the incidence of procedure or device related
SAEs from procedure to 7 (±1) days post-procedure or hospital discharge, whichever is longer,
for patients with right-sided SVT or 3 months (±2 weeks) post-procedure for patients with
atrial fibrillation. Secondary safety objectives were to demonstrate safety (operative and
post-operative complications) over the 12 months post-procedure.
Performance: The primary performance endpoint is to demonstrate successful catheter
deployment, irrigation and ablation at the target area during supra-ventricular cardiac
ablation. The secondary performance endpoint is to demonstrate successful and effective
contact force reading between catheter tip and heart wall during mapping and ablation at all
locations and all angulations.
Efficacy: Secondary effectiveness objectives will consider acute and chronic elimination of
the target arrhythmia, the cost-effectiveness of the system and procedure-related parameters
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