This is a prospective, interventional, observational, unblinded, single-arm, multicenter registry of younger and older subjects with drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation.
This study is to measure the "real-world" acute procedural outcomes (procedural efficiency, acute safety, and effectiveness at one year) associated with use of the NAVISTAR® THERMOCOOL® SF Catheter in a clinical setting in subjects with drug refractory, recurrent symptomatic paroxysmal atrial fibrillation.
Study Type
OBSERVATIONAL
Enrollment
511
Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly.
Total Fluoroscopy Time
The fluoroscopy time will be measured for each phase (access, mapping, ablation, and validation) of the procedure and summed to derive the total time.
Time frame: Day 0 (procedure)
Total Procedure Time
Time frame: Day 0 (procedure)
Acute Procedural Success
Confirmation of entrance and/or exit block across all targeted pulmonary veins.
Time frame: Day 0 (procedure)
Mean Number of Radiofrequency (RF) Applications
RF applications is defined as the number of times RF energy is delivered during the procedure.
Time frame: Day 0 (procedure)
Total Radiofrequency (RF) Time
Total RF time is defined as the total time that RF energy is delivered during the procedure.
Time frame: Day 0 (procedure)
Fluid Volume Delivered Via Ablation Catheter
Time frame: Day 0 (procedure)
Number of Patients With Repeat Ablations
Time frame: 1 year
Post-procedure AF Symptoms
Symptoms attributed to paroxysmal atrial fibrillation reported at 12 month visit
Time frame: 12 Month Visit
Number of Subjects With Lost Work Days, Related to AF, at 12 Month Visit
Time frame: 12 Month Visit
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Heart Center Research, LLC
Huntsville, Alabama, United States
Alaska Heart Institute, LLC
Anchorage, Alaska, United States
Arizona Heart Hospital
Phoenix, Arizona, United States
Scottsdale Healthcare Research Institute
Scottsdale, Arizona, United States
Scripps Clinical Research
La Jolla, California, United States
San Diego Cardiac Center
San Diego, California, United States
UCSF Medical Center
San Francisco, California, United States
JFK Medical Center
Atlantis, Florida, United States
Florida Hospital Memorial Medical Center
Daytona Beach, Florida, United States
St. Vincent's Ambulatory Care, Inc.
Jacksonville, Florida, United States
...and 35 more locations
Number of Patients With Inpatient Hospital Visit(s) Related to Atrial Fibrillation
Time frame: 12 Month Visit
Number of Patients With Outpatient Emergency Visits Related to Atrial Fibrillation
Time frame: 12 Month Visit
Change in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score
Change is calculated as 12 month overall AFEQT score minus score at screening. An overall AFEQT score ranges from 0 to 100. A score of 0 corresponds to complete disability (or responding "extremely" limited, difficult or bothersome to all questions answered), while a score of 100 corresponds to no disability (or responding "not at all" limited, difficult or bothersome to all questions answered). Therefore a positive change in score corresponds to improvement in AF symptoms.
Time frame: Screening to 12 Month Visit