SPHERE Per-AF Post-Approval Study

Running, not enrolling

Conditions studied: Persistent Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT06858306

Run by

Medtronic Cardiac Ablation Solutions

People needed

200

Starts

2025-09-25

Expected to finish

2030-10-01

Last updated by the study team

2026-06-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A diagnosis of recurrent symptomatic persistent AF (continuous AF sustained longer than 7 days but less than 12 months)
• Refractory (i.e. not effective, not tolerated, or not desired) to at least one Class I or III antiarrhythmic drug (AAD)
• Patient is ≥ 18 years of age
• Planned de novo pulmonary vein isolation procedure using commercially available Sphere-9™ Catheter and Affera Ablation System
• Patient is willing and able to comply with study requirements and give informed consent

You may not qualify if…

• Long-standing persistent AF (continuous AF sustained >12 months)
• Prior left atrial catheter or surgical ablation
• Life expectancy <36 months
• Presence of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function)
• Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of this study not pre-approved by Medtronic

Where it is running

• University of Alabama at Birmingham Hospital — Birmingham, Alabama, United States
• Sarasota Memorial Hospital — Sarasota, Florida, United States
• Piedmont Heart Institute — 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
• Texas Health Resources — Fort Worth, Texas, United States
• Houston Methodist Hospital — Houston, Texas, United States
• University of Virginia Medical Center — Charlottesville, Virginia, United States
• Centra Medical Group Stroobants Cardiovascular Center — Lynchburg, Virginia, United States

Full record on ClinicalTrials.gov

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