The study is a prospective, single-arm, pre-market clinical study and will enroll up to 300 subjects at up to 26 sites in the United States (US) for analysis of primary objectives. No single site may contribute more than 15% of the enrollments.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
300
Pulmonary Vein Isolation using the Sphere-360 Pulsed Field Ablation Catheter with the Affera Mapping and Ablation System
Arrhythmia Research Group
Freedom from Atrial Tachyarrhythmia Recurrence Through 12 Months Post-Ablation
Freedom from documented recurrence of atrial fibrillation, atrial tachycardia, or atrial flutter based on electrocardiographic data through 12 months (365 days) and excluding a 90-day blanking period. The study requires 24-hour Holter monitoring at 6 and 12 months in addition to weekly and symptomatic trans-telephonic monitoring (TTM) transmissions through 12 months, and 12-lead ECGs at all follow up visits. Atrial tachyarrhythmia observed via any of those instruments, as well as acute procedural failure, repeat ablation, cardioversion, an increase in anti-arrhythmic drugs, or use of amiodarone at any time during the study will constitute a failure.
Time frame: Index ablation procedure through 12 months of follow up.
Incidence of Device- and Procedure-Related Serious Adverse Events Through 6 Months
Primary safety events (device- and procedure-related serious adverse events, as adjudicated by the Clinical Events Committee) for the Sphere-360 Catheter and Affera Mapping and Ablation System: Within 7 days: heart block, major bleeding needing transfusion, MI, permanent phrenic nerve paralysis, pulmonary edema, severe pericarditis, significant effusion/tamponade, stroke/CVA, systemic/pulmonary embolism needing intervention, TIA, vagal nerve injury causing esophageal dysmotility/gastroparesis, vascular access complications needing intervention, AKI needing dialysis or hospitalization \>48h or prolonged \>48h, death, any device/procedure-related CV/pulmonary event causing/prolonging hospitalization \>48h (excludes recurrent AF/AT/AFL). Within 3 months: atrioesophageal/esophago-pericardial fistula, esophageal perforation (device/procedure related; excludes TEE/nasogastric tube injury). Within 6 months: pulmonary vein stenosis (≥70% diameter reduction).
Time frame: Index ablation procedure through 6 months of follow up.
Secondary Endpoint: Quality of Life (AFEQT)
Change in AFEQT score from baseline to 12 months. The AFEQT is an AF-specific health-related quality of life questionnaire, scored 0-100 (higher scores indicate better quality of life).
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Jonesboro, Arkansas, United States
Scripps Memorial Hospital
La Jolla, California, United States
Mercy General Hospital
Sacramento, California, United States
NCH Rooney Heart Institute
Naples, Florida, United States
Memorial Health University Medical Center
Savannah, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Kansas City Heart Rhythm Institute (Midwest Heart and Vascular Specialist)
Overland Park, Kansas, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Southcoast Health System
Fall River, Massachusetts, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States
...and 14 more locations
Time frame: Index ablation procedure through 12 months of follow up.
Secondary Endpoint: Quality of Life (EQ-5D)
Change in EQ-5D composite score from baseline to 12 months. The EQ-5D is a standardized instrument for generic health status, with composite scores indexed to a US reference population.
Time frame: Index ablation procedure through 12 months follow up.