This is a prospective, multicenter, non-randomized observational study of subjects 18 years and older undergoing RF ablation with drug refractory recurrent symptomatic paroxysmal Atrial Fibrillation (AF).
This study is purposed to measure "real world" acute procedural outcomes (procedural efficiency and acute safety) associated with use of the CARTO® 3 System and real time intracardiac ultrasound in a clinical setting in subjects with drug refractory recurrent symptomatic paroxysmal AF.
Study Type
OBSERVATIONAL
Enrollment
234
NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)
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 frame: Day 0
Total Procedure Time
The procedure time will be measured for each phase (access, mapping, ablation, and validation) of the procedure and summed to derive the total.
Time frame: Day 0
Acute Procedural Success
Acute success will be defined as confirmation of pulmonary vein isolation by entrance block, exit block, and/or periostial block of all targeted pulmonary veins.
Time frame: Day 0
Mean Number of Radiofrequency (RF) Applications
RF application is defined as the number of times RF energy is delivered during the procedure.
Time frame: Day 0
Total Radiofrequency (RF) Time
Total RF time is defined as the total time RF is delivered during the procedure.
Time frame: Day 0
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
AZ Heart Rhythm Research Center
Phoenix, Arizona, United States
Scottsdale Healthcare Research Institute
Scottsdale, Arizona, United States
Santa Barbara Cottage Hospital
Santa Barbara, California, United States
University of Colorado Denver
Aurora, Colorado, United States
JFK Medical Center
Atlantis, Florida, United States
East Coast Institute for Research, LLC. St. Vincent's Ambulatory Care, Inc.
Jacksonville, Florida, United States
Osceola Regional Medical Center
Kissimmee, Florida, United States
Tallahassee Research Institute
Tallahassee, Florida, United States
Pepin Heart Hospital
Tampa, Florida, United States
Northeast Georgia Heart Center, PC
Gainsville, Georgia, United States
...and 16 more locations