THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation CONTINUED ACCESS

Phase 3

Completed

Brief Summary: This is a prospective, multicenter, non-randomized continued access clinical evaluation utilizing the THERMOCOOL® SMARTTOUCH™ catheter.

Detailed Description: The device is currently under investigation with IDE #G110030. This continued access study will enroll subjects that have participated in the Smart-AF IDE study. Subjects with drug refractory symptomatic paroxysmal atrial fibrillation (PAF) will be considered for this study. Effectiveness and safety endpoints have been defined and will be evaluated post treatment.

Recruitment & Eligibility

Inclusion Criteria

Have had at least 3 atrial fibrillation episodes within 6 months of this study
Have failed at least one antiarrhythmic drug shown by repeated atrial fibrillation episodes
18 years of age or older

Exclusion Criteria including, but not limited to:

Exclusion Criteria

Not provided

Primary Outcome Measures

Name	Time	Method
Incidence of Primary Adverse Events Within Specified Study Period	12 months post procedure	Primary safety endpoint consists of primary adverse events (AE) within 7 days post procedure Or pulmonary vein stenosis and atrio-esophageal fistula events that occurred within 12 months post-procedure. Primary adverse events include death, myocardial infarction, pulmonary vein stenosis, diaphragmatic paralysis, atrio-esophageal fistula, transient ischemic attack, stroke / cerebrovascular accident, thromboembolism, pericarditis, cardiac tamponade, pericardial effusion, pneumothorax, atrial perforation, vascular access complications, pulmonary edema, initial and prolonged hospitalization (excluding those due to pre-existing arrhythmia recurrence), heart block.
Percentage of Subjects Achieved Freedom From Atrial Tachyarrhythmias	Day 91-361	Freedom from documented symptomatic atrial fibrillation/atrial tachycardia/atrial flutter (hereinafter collectively referred to as "atrial tachyarrhythmias") based on electrocardiographic data during the effectiveness evaluation period (Day 91-361). Acute procedure failures, antiarrhythmic drug(AAD) changes and repeat ablation occurring during evaluation period were deemed as primary effectiveness failures

Secondary Outcome Measures

Name	Time	Method
Late Onset Serious Adverse Events	From 31 days post procedure to month 12	Late onset serious adverse events (SAEs) are those non-primary SAEs occurred after 31 days post procedure
Peri-procedural Serious Adverse Events	Within 8-30 days post procedure	Peri-procedural serious adverse events (SAEs) are those non-primary SAEs occurred within 8-30 days post procedure
Percentage of Subjects Achieved Acute Effectiveness	5 hours of procedure time	Acute effectivenesss is defined as confirmation of entrance block into all Pulmonary veins

Locations (20): University of Alabama, Birmingham
🇺🇸
Birmingham, Alabama, United States
Stanford University School of Medicine
🇺🇸
Stanford, California, United States
Florida Hospital
🇺🇸
Orlando, Florida, United States
Piedmont Heart Institute
🇺🇸
Atlanta, Georgia, United States
Loyola University Chicago
🇺🇸
Maywood, Illinois, United States
University of Kansas Hospitals
🇺🇸
Kansas City, Kansas, United States
Johns Hopkins Hospital
🇺🇸
Baltimore, Maryland, United States
Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States
Brigham and Women's Hospital
🇺🇸
Boston, Massachusetts, United States
Abbott Northwestern Hospital
🇺🇸
Minneapolis, Minnesota, United States
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University of Alabama, Birmingham
🇺🇸Birmingham, Alabama, United States