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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
77
radiofrequency ablation of atrial fibrillation or SVT
Number of Subjects With Operative and Post-operative Serious Adverse Events
For Right SVT patients 7 days (±1 day) following the index procedure or until hospital discharge whichever is longer. For AF patients 3 months (±2 weeks)following the index procedure.
Time frame: 3 months for AF arm; 7 days for the right SVT arm
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