Irrigated Ablation System Evaluation for Atrial Fibrillation (AF)
- Conditions
- Paroxysmal Atrial Fibrillation
- Interventions
- Device: FDA approved Open Irrigated RF Ablation SystemDevice: SJM Irrigated Cardiac Ablation System
- Registration Number
- NCT01056328
- Lead Sponsor
- Abbott Medical Devices
- Brief Summary
The purpose of this study is to test the safety and effectiveness of an Irrigated Ablation System for the treatment of symptomatic paroxysmal atrial fibrillation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 324
-
Age 18 years or older
-
Signed Patient Informed Consent Form
-
Able and willing to comply with all pre-, post-, and follow-up testing and requirements
-
Failure of at least one anti-arrhythmic medication (AAD) for paroxysmal atrial fibrillation* [class I or III, or AV nodal blocking agents such as beta blockers (BB) and calcium channel blockers (CCB)] as evidenced by recurrent symptomatic paroxysmal atrial fibrillation*, or intolerable side effects due to AAD
-
Subjects with symptomatic paroxysmal atrial fibrillation (PAF)*
- PAF is defined as recurrent atrial fibrillation (AF) that terminates spontaneously within seven days.
- Atrial fibrillation (AF) secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
- Previous ablation for AF
- History of any valvular cardiac surgical procedure
- Coronary artery bypass grafting (CABG) procedure within the last six months
- Awaiting cardiac transplantation or other cardiac surgery within the next 12 months
- Left atrial thrombus
- History of a documented thromboembolic event within the past one (1) year
- Diagnosed atrial myxoma
- An implanted implantable cardioverter defibrillator (ICD)
- Significant pulmonary disease, (e.g. restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms
- Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study
- Women who are pregnant (by history of menstrual period or pregnancy test if the history is considered unreliable)
- Acute illness or active systemic infection or sepsis
- Unstable angina
- Myocardial infarction within the previous two months
- Left ventricular ejection fraction (LVEF) <40% as determined by pre-procedure transthoracic echocardiogram (TTE)
- History of blood clotting or bleeding abnormalities
- Contraindication to anticoagulation (i.e. heparin or warfarin)
- Contraindication to computed tomography/magnetic resonance angiography (CT/MRA) procedure
- Life expectancy less than 12 months
- Enrollment in an investigational study evaluating another device or drug
- Uncontrolled heart failure or New York Heart Association (NYHA) class III or IV heart failure
- An intramural thrombus tumor, or other abnormality that precludes catheter introduction or manipulation
- Presence of a condition that precludes vascular access
- Left atrial size ≥ 50 mm as determined by pre-procedure TTE
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description FDA approved Open Irrigated Radio Frequency Ablation System FDA approved Open Irrigated RF Ablation System - St. Jude Medical Cardiac Ablation System SJM Irrigated Cardiac Ablation System -
- Primary Outcome Measures
Name Time Method Confirmation of Entrance Block in the Pulmonary Veins 20 minutes after initial isolation Incidence of Adverse Events Included in the Pre-specified Composite 7 days Atrial perforation, atrio-esophageal fistula, cardiac tamponade, cerebrovascular accident, death, diaphragmatic paralysis, hospitalization, myocardial infarction, pericaridal effusion, pericarditis, pulumonary edema, pulmonary vein stenosis, thromboembolism, transient ischemic attack, and vascular access complications.
Incidence of Adverse Events Included in the Pre-specified Composite. 12 months
- Secondary Outcome Measures
Name Time Method Documented (> 30 Seconds) Asymptomatic Episodes of Atrial Fibrillation (AF), Atrial Flutter (AFL), or Atrial Tachicardia (AT) After the Blanking Period 12 months Early Onset (Within 90 Days) of SAE/Non-serious AEs and Late Onset (After 90 Days) SAEs 12 months Early onset (within 90 days) of Serious Adverse Events (SAE)/Non-serious Adverse Events (AEs) and late onset (after 90 days) Serious Adverse Events (SAEs)
Trial Locations
- Locations (30)
Baylor Heart & Vascular Hospital
🇺🇸Dallas, Texas, United States
NYU Langone Medical Center
🇺🇸New York, New York, United States
Good Samaritan Hospital
🇺🇸Los Angeles, California, United States
Colorado Cardiac Alliance
🇺🇸Colorado Springs, Colorado, United States
Mount Sinai Hospital
🇺🇸New York, New York, United States
University of Kansas Hospital
🇺🇸Kansas City, Kansas, United States
Emory University Hospital, Midtown
🇺🇸Emory, Georgia, United States
Spectrum Health
🇺🇸Grand Rapids, Michigan, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Sunybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
Arizona Arrhythmia Consultants/Scottsdale Healthcare
🇺🇸Scottsdale, Arizona, United States
Inova Fairfax Hospital / Inova Heart and Vascular Institute
🇺🇸Falls Church, Virginia, United States
Severance Hospital
🇰🇷Seoul, Korea, Republic of
University of Virginia Health System
🇺🇸Charlottesville, Virginia, United States
Diagnostic Cardiology Associates, P.A.; St. Vincents Medical Center
🇺🇸Jacksonville, Florida, United States
The Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
University of Rochester
🇺🇸Rochester, New York, United States
Doylestown Hospital
🇺🇸Doylestown, Pennsylvania, United States
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
University of Californai, San Diego Medical Center
🇺🇸San Diego, California, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
Washington Adventist Hospital
🇺🇸Takoma Park, Maryland, United States
MAHI, Saint Luke's Hospital
🇺🇸Kansas City, Missouri, United States
University Hospitals Case Medical Center
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Centennial Medical Center
🇺🇸Nashville, Tennessee, United States
Texas Cardiac Arrhythmia Research Foundation
🇺🇸Austin, Texas, United States
The Methodist Hospital Research Institute
🇺🇸Houston, Texas, United States
Intermountain Medical Center
🇺🇸Salt Lake City, Utah, United States