None listed
Conditions
Brief summary
The study is intended to assess the safety and preliminary performance data for treatment of symptomatic paroxysmal atrial fibrillation using the Apama Cardiac Ablation System. The study will be a prospective, multicenter, non-randomized investigation.
Interventions
Apama RF Balloon Catheter system used for radiofrequency ablation; RF energy administered to tissue at 8-10 Watts power over durations of 60 - 90 seconds with irrigation of 30 ml/minute. Procedural times can vary from one hour to approximately three hours depending upon the ability to isolate veins using radiofrequency and to restore rhythm to normal sinus.
Sponsors
Boston Scientific
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
History of symptomatic paroxysmal and atrial fibrillation within the past year documented by ECG Suitable candidate for catheter non-emergent intra-cardiac mapping and ablation
Exclusion criteria
Structural heart disease of clinical significance including previous cardiac surgery (excluding CABG or mitral valve repair) Documented EF <30% Left atrial diameter of >55mm Contraindication to anticoagulation therapy Unstable angina or ongoing myocardial ischemia Myocardial infarction within 3 months of enrollment Congenital heart disease where the underlying abnormality increases the risk of the ablation Prior Atrial Septal Defect or Patent Foramen Ovale Closure with a device using a transcatheter percutaneous approach Hypertrophic cardiomyopathy (LV septal wall thickness >1.5cm) Pulmonary hypertension (>50mm Hg) Prior ablation for atrial fibrillation Enrollment in any other ongoing arrhythmia study protocol Patients with severely impaired kidney function as measured by Cockcroft-Gault Glomerular Filtration Rate (GFR) 3 with a GFR < 29 Active gastrointestinal bleeding, infection or fever (>100.5/38C) or sepsis Short life expectancy (<1 year) due to illness such as cancer, pulmonary,hepatic or renal disease Significant anemia (hemoglobin < 8.0 / dl) Severe uncontrolled systemic hypertension with systolic >200mm Hg within ast 30 days Documented anaphylaxis during previous exposure to contrast media Bleeding or clotting disorders or thrombotic disorder under treatment Uncontrolled diabetes Women who are pregnant and not willing to use contraception for the duration of the study Severe COPD (identified by an FEV1 <1) Unwilling or unable to comply with any protocol or follow up requirements
Outcome results
None listed