🏛️ Verified NIH Record • Updated 2026-06-17
SPHERE Per-AF Post-Approval Study (NCT06858306)
SPHERE Per-AF Post-Approval Study, an Addendum to the Affera Global Registry
🔵 Active, Not Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: Medtronic Cardiac Ablation Solutions
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Alabama at Birmingham Hospital — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (14 Sites)
- University of Alabama at Birmingham Hospital — Birmingham, Alabama
- Sarasota Memorial Hospital — Sarasota, Florida
- Piedmont Heart Institute — Atlanta, Georgia
- Minneapolis Heart Institute Foundation — Minneapolis, Minnesota
- Mayo Clinic — Rochester, Minnesota
- Montefiore Medical Center — New York, New York
- Atrium Health Carolinas Medical Center — Charlotte, North Carolina
- OhioHealth — Columbus, Ohio
- Doylestown Health Cardiology — Doylestown, Pennsylvania
- Allegheny General Hospital — Pittsburgh, Pennsylvania
- Texas Health Resources — Fort Worth, Texas
- Houston Methodist Hospital — Houston, Texas
- University of Virginia Medical Center — Charlottesville, Virginia
- Centra Medical Group Stroobants Cardiovascular Center — Lynchburg, Virginia
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.