NCT06858306|Active Not RecruitingFDA Device
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Sponsor study identifier
observational
200
1 country
14
Study Start
September 25, 2025
Actual (reported)Primary Completion
October 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 26, 2025
Actual (reported)March 5, 2025
Actual (reported)September 25, 2025
Actual (reported)October 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
October 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Safety Objective
Estimate the primary safety adverse event (AE) rate for ablation using the Sphere-9™ Catheter and Affera™ Ablation System.
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.
Through 36 months Post-Procedure
De novo pulmonary vein isolation procedure using commercially available Sphere-9™ Catheter and Affera™ Ablation System
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Subjects 18 years or older with a planned de novo procedure using commercially available Sphere-9™ Catheter and Affera™ Ablation System.
University of Alabama at Birmingham Hospital
Birmingham, Alabama, 35294, United States
Sarasota Memorial Hospital
Sarasota, Florida, 34239, United States
Piedmont Heart Institute
Atlanta, Georgia, 30309, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Montefiore Medical Center
New York, New York, 10467, United States
Atrium Health Carolinas Medical Center
Charlotte, North Carolina, 28230, United States
First Submitted
February 26, 2025
First Posted
March 5, 2025
Study Start
September 25, 2025
Actual (reported)Primary Completion
October 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Lattice vs Pentaspline Comparative Evaluation in Persistent AF
Contact the study team to confirm eligibility.
OhioHealth
Columbus, Ohio, 43214, United States
Doylestown Health Cardiology
Doylestown, Pennsylvania, 18901, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
Texas Health Resources
Fort Worth, Texas, 76104, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
University of Virginia Medical Center
Charlottesville, Virginia, 22903, United States
Centra Medical Group Stroobants Cardiovascular Center
Lynchburg, Virginia, 24501, United States
Study Completion
October 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
June 18, 2026
Record last verified: 2026-05
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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