CARTO® 3 System and Real Time Intracardiac Ultrasound
- Conditions
- Atrial FibrillationParoxysmal AF
- Interventions
- Device: Catheter Ablation
- Registration Number
- NCT01716663
- Lead Sponsor
- Biosense Webster, Inc.
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 234
- Drug refractory, recurrent symptomatic paroxysmal AF
- Age 18 years or older
- Patients able and willing to provide written informed consent to participate in the study and comply with study requirements
- Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
- Previous ablation for atrial fibrillation
- AF episodes that last longer than 30 days
- Uncontrolled heart failure, or NYHA Class III or IV heart failure
- Documented intra-atrial thrombus or other abnormality on pre-ablation imaging
- Contraindication to anticoagulation
- Stroke, cardiac surgery, unstable angina, myocardial infarction or percutaneous coronary intervention within the past 3 months
- Awaiting cardiac transplantation
- Heart disease for which corrective surgery is anticipated within 6 months
- Enrollment in other investigational drug or device study
- Subjects unwilling to comply with protocol or follow-up requirements
- Patients who are pregnant
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Experimental: Catheter Ablation Catheter Ablation These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.
- Primary Outcome Measures
Name Time Method Total Fluoroscopy Time Day 0 The fluoroscopy time will be measured for each phase (access, mapping, ablation, and validation) of the procedure and summed to derive the total.
- Secondary Outcome Measures
Name Time Method Total Procedure Time Day 0 The procedure time will be measured for each phase (access, mapping, ablation, and validation) of the procedure and summed to derive the total.
Acute Procedural Success Day 0 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.
Mean Number of Radiofrequency (RF) Applications Day 0 RF application is defined as the number of times RF energy is delivered during the procedure.
Total Radiofrequency (RF) Time Day 0 Total RF time is defined as the total time RF is delivered during the procedure.
Trial Locations
- Locations (26)
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Scott & White Memorial Hospital
🇺🇸Temple, Texas, United States
Lankenau Institute for Medical Research
🇺🇸Wynnewood, Pennsylvania, United States
Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
Santa Barbara Cottage Hospital
🇺🇸Santa Barbara, California, United States
AZ Heart Rhythm Research Center
🇺🇸Phoenix, Arizona, United States
Scottsdale Healthcare Research Institute
🇺🇸Scottsdale, Arizona, United States
Geisinger Heart Institute
🇺🇸Wilkes-Barre, Pennsylvania, United States
The Methodist Hospital Research Institute
🇺🇸Houston, Texas, United States
University of Colorado Denver
🇺🇸Aurora, Colorado, United States
Wellmont CVA Heart Institute
🇺🇸Kingsport, Tennessee, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Osceola Regional Medical Center
🇺🇸Kissimmee, Florida, United States
East Coast Institute for Research, LLC. St. Vincent's Ambulatory Care, Inc.
🇺🇸Jacksonville, Florida, United States
JFK Medical Center
🇺🇸Atlantis, Florida, United States
Tallahassee Research Institute
🇺🇸Tallahassee, Florida, United States
Northeast Georgia Heart Center, PC
🇺🇸Gainsville, Georgia, United States
Pepin Heart Hospital
🇺🇸Tampa, Florida, United States
Provena St. Joseph Medical Center
🇺🇸Joliet, Illinois, United States
Kettering Medical Center
🇺🇸Kettering, Ohio, United States
Washington Adventist Hospital CCVR
🇺🇸Takoma Park, Maryland, United States
Michigan CardioVascular Institute
🇺🇸Saginaw, Michigan, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
St. Mary Medical Center
🇺🇸Newtown, Pennsylvania, United States
Northeast Baptist Hospital
🇺🇸San Antonio, Texas, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States