NAVISTAR® THERMOCOOL® SF Catheter: Observational Study
- Conditions
- Atrial FibrillationParoxysmal Arrhythmia
- Interventions
- Device: Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter)
- Registration Number
- NCT01585961
- Lead Sponsor
- Biosense Webster, Inc.
- Brief Summary
This is a prospective, interventional, observational, unblinded, single-arm, multicenter registry of younger and older subjects with drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 511
- Drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation
- Age 18 years or older
- Patients must be able and willing to provide written informed consent to participate in the study
- Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
- Previous ablation for atrial fibrillation
- Episodes of atrial fibrillation that last longer than 30 days and are terminated via cardioversion
- Uncontrolled heart failure, or NYHA Class III or IV heart failure
- Documented intra-atrial thrombus or other abnormality on pre-ablation echocardiogram
- Contraindication to anticoagulation
- Stroke, cardiac surgery, unstable angina, myocardial infarction or percutaneous coronary intervention within the past 3 months
- Awaiting cardiac transplantation
- Heart disease in which corrective surgery is anticipated within 6 months
- Enrollment in investigational drug, biologic 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 Catheter Ablation Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter) These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and have provided written informed consent to participate in the study, including consent to undergo catheter ablation with the study device.
- Primary Outcome Measures
Name Time Method Total Procedure Time Day 0 (procedure) Acute Procedural Success Day 0 (procedure) Confirmation of entrance and/or exit block across all targeted pulmonary veins.
Total Fluoroscopy Time Day 0 (procedure) The fluoroscopy time will be measured for each phase (access, mapping, ablation, and validation) of the procedure and summed to derive the total time.
- Secondary Outcome Measures
Name Time Method Fluid Volume Delivered Via Ablation Catheter Day 0 (procedure) Change in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score Screening to 12 Month Visit 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.
Total Radiofrequency (RF) Time Day 0 (procedure) Total RF time is defined as the total time that RF energy is delivered during the procedure.
Number of Patients With Inpatient Hospital Visit(s) Related to Atrial Fibrillation 12 Month Visit Number of Patients With Repeat Ablations 1 year Number of Subjects With Lost Work Days, Related to AF, at 12 Month Visit 12 Month Visit Mean Number of Radiofrequency (RF) Applications Day 0 (procedure) RF applications is defined as the number of times RF energy is delivered during the procedure.
Post-procedure AF Symptoms 12 Month Visit Symptoms attributed to paroxysmal atrial fibrillation reported at 12 month visit
Number of Patients With Outpatient Emergency Visits Related to Atrial Fibrillation 12 Month Visit
Trial Locations
- Locations (45)
Texas Heart Institute at St. Luke's Episcopal Hospital
🇺🇸Houston, Texas, United States
Arizona Heart Hospital
🇺🇸Phoenix, Arizona, United States
Alaska Heart Institute, LLC
🇺🇸Anchorage, Alaska, United States
Heart Center Research, LLC
🇺🇸Huntsville, Alabama, 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
JFK Medical Center
🇺🇸Atlantis, Florida, United States
Largo Medical Center
🇺🇸Largo, Florida, United States
Florida Hospital Memorial Medical Center
🇺🇸Daytona Beach, Florida, United States
UCSF Medical Center
🇺🇸San Francisco, California, United States
St. Vincent's Ambulatory Care, Inc.
🇺🇸Jacksonville, Florida, United States
Florida Hospital - Orlando
🇺🇸Orlando, Florida, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
St. Joseph's Hospital of Atlanta
🇺🇸Atlanta, Georgia, United States
University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
Cardiology Associates of Savannah
🇺🇸Savannah, Georgia, United States
Alexian Brothers Medical Center
🇺🇸Elk Grove Village, Illinois, United States
Prairie Education and Research Cooperative
🇺🇸Springfield, Illinois, United States
Lutheran Medical Group, LLC
🇺🇸Fort Wayne, Indiana, United States
University of Iowa Hospital & Clinics
🇺🇸Iowa City, Iowa, United States
Central Baptist Hospital
🇺🇸Lexington, Kentucky, United States
Baptist Hospital
🇺🇸Louisville, Kentucky, United States
Cardiovascular Research Foundation of Louisiana
🇺🇸Baton Rouge, Louisiana, United States
St. Luke's Mid American Heart Institute
🇺🇸Kansas City, Missouri, United States
Washington Adventist Hospital
🇺🇸Takoma Park, Maryland, United States
United Heart and Vascular Clinic
🇺🇸St. Paul, Minnesota, United States
Bryan LGH Heart Institute
🇺🇸Lincoln, Nebraska, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
The Cardiac Center of Creighton University
🇺🇸Omaha, Nebraska, United States
Morristown Medical Center
🇺🇸Morristown, New Jersey, United States
Bethesda North Hospital
🇺🇸Cincinnati, Ohio, United States
New York Presbyterian Hospital, Columbia University Medical Center
🇺🇸New York, New York, United States
Riverside Methodist Hospital
🇺🇸Columbus, Ohio, United States
Genesis Healthcare Systems
🇺🇸Zanesville, Ohio, United States
Central Bucks Specialists, LTD
🇺🇸Doylestown, Pennsylvania, United States
Albert Einstein Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Vanderbilt Heart and Vascular Institute
🇺🇸Nashville, Tennessee, United States
Centennial Heart
🇺🇸Nashville, Tennessee, United States
Plaza Medical Center
🇺🇸Grapevine, Texas, United States
Baylor All Saints Medical Center
🇺🇸Fort Worth, Texas, United States
Cardiac Study Center
🇺🇸Tacoma, Washington, United States
Bellin Memorial Hospital, Inc.
🇺🇸Green Bay, Wisconsin, United States
University of Kansas Hospitals
🇺🇸Kansas City, Kansas, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States