This is a prospective, multicenter, non-randomized clinical evaluation utilizing the THERMOCOOL SMARTTOUCH® SF catheter compared to a predetermined performance goal.
The purpose of this study is to demonstrate the safety and effectiveness of the THERMOCOOL SMARTTOUCH® SF catheter in the treatment of drug refractory symptomatic persistent atrial fibrillation (PsAF) following standard electrophysiology mapping and radio frequency (RF) ablation procedures.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
381
Radiofrequency Ablation
Primary Safety Endpoint - Percentage of Participants With Any PAE Within 7 Days
The primary safety endpoint is the incidence of any early onset (within 7 days of the initial and repeat AF ablation procedure) Primary Adverse Events (AE), which are listed below: * Death * Atrio-esophageal fistula\* * Cardiac Tamponade\*\*+/Perforation+ * Myocardial infarction (MI) * Stroke / Cerebrovascular accident (CVA) †, †† * Thromboembolism * Transient Ischemic Attack * Diaphragmatic paralysis * Pneumothorax * Heart block * PV stenosis\* * Pulmonary edema (Respiratory Insufficiency) * Pericarditis * Major Vascular access complication / bleeding
Time frame: 7 days (except as noted in analysis population description)
Effectiveness: Freedom From Documented Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes Through 15-month Follow-up
The primary effectiveness endpoint for this study will be freedom from documented atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) episodes through 15-month follow-up (post 3-Month Medication Adjustment Period followed by a 3-Month Therapy Consolidation period (Day 181-450)) and freedom from the following failure modes: * Acute Procedural Failure * Non-Study Catheter Failure * Repeat Ablation Failure * AAD Failure * Surgical Failure
Time frame: 15-month follow-up
Acute Procedural Success
Acute procedural success is defined as confirmation of entrance block in all pulmonary veins.
Time frame: Immediate post-procedure
15-Month Single Procedure Success
The 15-month single procedure success is defined as freedom from documented AF/AFL/AT recurrence (episodes \> 30 secs) during the Evaluation Period after a single ablation procedure. Any repeat ablation procedure during the Evaluation Period will be deemed effectiveness failure for this analysis.
Time frame: 15-Month
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Early Onset Serious Adverse Event (SAE)
Occurrence of Early Onset (within 7 days of initial ablation) Serious Adverse Event
Time frame: 7 days
Peri-Procedural Serious Adverse Event (SAE)
Peri-Procedural (\>7 to 30 days) Serious Adverse Event
Time frame: >7 to 30 days
Late Onset Serious Adverse Event (SAE)
Occurrence of Late Onset (\>30 days) Serious Adverse Event
Time frame: >30 days up to 15 months