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
RECRUITINGSarasota Memorial Hospital
Sarasota, Florida, United States
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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Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States
RECRUITINGMayo Clinic
Rochester, Minnesota, United States
RECRUITINGMontefiore Medical Center
New York, New York, United States
RECRUITINGOhioHealth
Columbus, Ohio, United States
RECRUITINGDoylestown Health Cardiology
Doylestown, Pennsylvania, United States
RECRUITINGAllegheny General Hospital
Pittsburgh, Pennsylvania, United States
RECRUITINGTexas Health Resources
Fort Worth, Texas, United States
RECRUITINGHouston Methodist Hospital
Houston, Texas, United States
RECRUITING...and 2 more locations