This is a prospective effectiveness and safety assessment of the study device during radiofrequency (RF) ablation treatment of patients with drug refractory symptomatic atrial fibrillation.
The purpose of this study is to assess the effectiveness and safety of the THERMOCOOL® SMARTTOUCH™ catheter in the treatment of drug refractory symptomatic paroxysmal atrial fibrillation (PAF) undergoing CPVI.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Pulmonary vein isolation by RF ablation treatment with the THERMOCOOL® SMARTTOUCH™ contact force sensing catheters (study device)
Percentage of Patients With Freedom From Documented Symptomatic Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes
The primary effectiveness endpoint for this study is freedom from documented symptomatic atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) episodes through 12-month follow-up after the index ablation procedure (includes a three-month blanking period).
Time frame: 12 Months
Percentage of Patients Where Acute Success Was Achieved
Confirmation of entrance block in all pulmonary veins (PVs) with an isoproterenol intravenous challenge 0.5h post procedure. Exit Block is optional for this study.
Time frame: 0.5 hours
Average Contact Force Per Pulmonary Vein Ablation Procedure
Contact force (CF) is the force (g) between the device tip and endocardial wall. Two subjects didn't have CF data
Time frame: 1 day during procedure
Percent of Subjects With Pulmonary Vein Reconnection for the Index Procedure
Percentage of subjects with PV reconnection after the first ablation
Time frame: 1 day during procedure
Procedure Time, Ablation Time and Fluoroscopy Time
Procedure Time, Ablation Time and Fluoroscopy Time in minutes
Time frame: 1 day during procedure
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