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SPHERE Per-AF Post-Approval Study
NCT06858306 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DEVICE Sphere-9™ Catheter and Affera™ Ablation System
Study Locations (12)
Minnesota
- Minneapolis Heart Institute Foundation — Minneapolis
- Mayo Clinic — Rochester
Pennsylvania
- Doylestown Health Cardiology — Doylestown
- Allegheny General Hospital — Pittsburgh
Texas
- Texas Health Resources — Fort Worth
- Houston Methodist Hospital — Houston
Virginia
- University of Virginia Medical Center — Charlottesville
- Centra Medical Group Stroobants Cardiovascular Center — Lynchburg
Alabama
- University of Alabama at Birmingham Hospital — Birmingham
Florida
- Sarasota Memorial Hospital — Sarasota
New York
- Montefiore Medical Center — New York
Ohio
- OhioHealth — Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2025-09-25 |
| Est. Completion | 2030-10 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06858306
The ClinicalTrials.gov registry entry for NCT06858306 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medtronic Cardiac Ablation Solutions, which has 12 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Persistent Atrial Fibrillation appearing as the primary indexed condition, and to 1 intervention — of which Sphere-9™ Catheter and Affera™ Ablation System is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06858306 reports 12 study locations spanning 8 distinct geographic areas — top geographies include Minnesota, Pennsylvania, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06858306 about?
NCT06858306 is a clinical study titled "SPHERE Per-AF Post-Approval Study". 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.
What is the current status of trial NCT06858306?
This trial is currently recruiting. The enrollment target is 200 participants. The study started on 2025-09-25. Estimated completion is 2030-10.
What conditions does trial NCT06858306 study?
This clinical trial studies the following conditions: Persistent Atrial Fibrillation. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06858306?
The interventions under investigation include: Sphere-9™ Catheter and Affera™ Ablation System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06858306?
This trial is sponsored by Medtronic Cardiac Ablation Solutions, which has 12 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06858306 being conducted?
This trial has 12 study locations across Alabama, Florida, Minnesota, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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