THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation CONTINUED ACCESS
- Conditions
- Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation
- Interventions
- Device: THERMOCOOL® SMARTTOUCH™ Catheter
- Registration Number
- NCT01639495
- Lead Sponsor
- Biosense Webster, Inc.
- 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
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 148
- 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:
- Have had previous ablation for atrial fibrillation
- Have take amiodarone within 6 months of this study
- Have had any heart surgery within the last 60 days
- Have had a heart attack within the last 60 days
- Females who are pregnant or breast feeding
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description THERMOCOOL® SMARTTOUCH™ Catheter THERMOCOOL® SMARTTOUCH™ Catheter -
- 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
Trial Locations
- Locations (20)
Loyola University Chicago
🇺🇸Maywood, Illinois, United States
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Abbott Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
Stanford University School of Medicine
🇺🇸Stanford, California, United States
Piedmont Heart Institute
🇺🇸Atlanta, Georgia, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
The Valley Hospital
🇺🇸Ridgewood, New Jersey, United States
Mt. Sinai School of Medicine
🇺🇸New York, New York, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
University of Pennslyvania
🇺🇸Philadelphia, Pennsylvania, United States
Texas Cardiac Arrhythmia Foundation
🇺🇸Austin, Texas, United States
University of Kansas Hospitals
🇺🇸Kansas City, Kansas, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
University of Alabama, Birmingham
🇺🇸Birmingham, Alabama, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
University of Oklahoma
🇺🇸Oklahoma City, Oklahoma, United States
Florida Hospital
🇺🇸Orlando, Florida, United States