New heart ablation device under scrutiny for persistent AF

NCT ID NCT06858306

Ongoing Disease control Sponsor: Medtronic Cardiac Ablation Solutions Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows 200 adults with persistent atrial fibrillation (a type of irregular heartbeat lasting more than 7 days but less than a year) who are treated with the Sphere-9 catheter and Affera ablation system. The goal is to see how safe the procedure is and how well it prevents the return of abnormal heart rhythms over 3 years. Participants must have already tried at least one heart rhythm medication without success.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Sphere-9™ Catheter and Affera™ Ablation System (a device that uses heat energy to destroy tiny areas of heart tissue causing abnormal rhythms)
What this could lead to: If successful, this study could confirm that the Sphere-9 and Affera system is a safe and effective way to control persistent atrial fibrillation, helping patients stay free from irregular heartbeats for years.
What could go wrong: This is an observational study, not a randomized trial, so results may be less definitive. The procedure carries risks like bleeding, infection, or heart damage, and some patients may still have arrhythmia recurrence.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

atrial fibrillation persistent atrial fibrillation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

PERSISTENT ATRIAL FIBRILLATION

Contacts and locations

Locations

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States
Atrium Health Carolinas Medical Center

Charlotte, North Carolina, 28230, United States
Centra Medical Group Stroobants Cardiovascular Center

Lynchburg, Virginia, 24501, United States
Doylestown Health Cardiology

Doylestown, Pennsylvania, 18901, United States
Houston Methodist Hospital

Houston, Texas, 77030, United States
Mayo Clinic

Rochester, Minnesota, 55905, United States
Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States
Montefiore Medical Center

New York, New York, 10467, United States
OhioHealth

Columbus, Ohio, 43214, United States
Piedmont Heart Institute

Atlanta, Georgia, 30309, United States
Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States
Texas Health Resources

Fort Worth, Texas, 76104, United States
University of Alabama at Birmingham Hospital

Birmingham, Alabama, 35294, United States
University of Virginia Medical Center

Charlottesville, Virginia, 22903, United States

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