SPHERE Per-AF Post-Approval Study is a prospective, multi-center, non-randomized, observational trial. Subjects will be treated with the Sphere-9™ Catheter and Affera™ Ablation System and followed through 36 months.
The purpose of the study is to evaluate the long-term effectiveness and safety of the Sphere-9™ Catheter and Affera™ Ablation System in a post-approval setting for the treatment of drug refractory, recurrent, symptomatic, persistent AF (episode duration less than one year).
Study Type
OBSERVATIONAL
Enrollment
200
De novo pulmonary vein isolation procedure using commercially available Sphere-9™ Catheter and Affera™ Ablation System
University of Alabama at Birmingham Hospital
Birmingham, Alabama, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
Piedmont Heart Institute
Primary Safety Objective
Estimate the primary safety adverse event (AE) rate for ablation using the Sphere-9™ Catheter and Affera™ Ablation System.
Time frame: Through 180 days Post-Procedure
Primary Effectiveness Objective
Estimate the 36-month freedom from atrial fibrillation (AF), atrial tachycardia (AT) or atrial flutter (AFL) recurrence following ablation procedure using the Sphere-9™ Catheter and Affera™ Ablation System.
Time frame: Through 36 months Post-Procedure
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Atlanta, Georgia, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Montefiore Medical Center
New York, New York, United States
Atrium Health Carolinas Medical Center
Charlotte, North Carolina, United States
OhioHealth
Columbus, Ohio, United States
Doylestown Health Cardiology
Doylestown, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
...and 4 more locations