The Linear II study is a prospective, single center, non-randomized, interventional feasibility study with the purpose of assessing acute safety of the Multi-Electrode Linear Type Ablation Catheter and the performance of the product when used for the treatment of symptomatic CTI (cavotricuspid isthmus) dependent right atrial flutter.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Safety
Incidence of early onset (within 7 days of ablation procedure) primary AEs
Time frame: 7 Days
Acute performance
Acute procedural success as confirmed complete bidirectional conduction block across the CTI (assess ≥30 min following last RF application)
Time frame: This outcome measure will be assessed during the procedure but after 30 minutes (or more) of the initial ablation
Safety
Incidence of Serious Adverse Events during follow-up
Time frame: Until one-month follow-up
Acute Efficacy
Right atrial flutter recurrence within 30 days
Time frame: Within 30 Days
Procedural data
Ablation parameters, including: * Total RF ablation time * Temperature * Contact Force Procedural time Total fluoroscopy time
Time frame: During Procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.