To demonstrate that ablation with the Therapy™ Cool Flex™ Irrigated Ablation System is effective in the treatment of typical atrial flutter (cavo-tricuspid dependent) and that its use does not result in an unacceptable risk of intra-procedural, serious cardiac adverse events.
This will be a prospective, multi-center and non-randomized study. All treated patients will receive ablation therapy for typical atrial flutter using the TherapyTM Cool FlexTM Irrigated Ablation System. Historical data from combined published (PMA P060019 Cool Path) and reported (IDE G090109 Cool Path Duo) Atrial Flutter studies will be used to determine performance goals for study endpoints.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
The investigational components of the Therapy™ Cool Flex™ Irrigated Ablation System consist of: * Therapy™ Cool Flex™ 4mm Irrigated Ablation Catheter * IBI 1500T9 V1.43 RF Generator
St. Joseph's Hospital-Heart Rhythm Specialists, PC
Primary Safety: Incidence of Composite, Serious Adverse Events Within 7 Days Post-Procedure
Primary safety is defined as the incidence of composite, serious adverse events within 7 days post-procedure, regardless of whether a determination can be made regarding device relatedness.
Time frame: 7 days
Primary Efficacy
Primary efficacy or acute success is defined as achievement of bi-directional block in the cavo-tricuspid isthmus and non-inducibility of typical atrial flutter at least 30 minutes following the last RF ablation with the investigational system.
Time frame: 30 minutes
Secondary Efficacy
Secondary efficacy or chronic success is defined as freedom from recurrence of typical atrial flutter 3 mos. post ablation. Flutter recurrence will be documented on an ECG. Repeat ablations, new antiarrhythmia medications or increase in the existing anti-arrhythmic medications during the 3 mos. post ablation are considered chronic failures.
Time frame: 3 months
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