New heart ablation device under scrutiny for persistent AF
NCT ID NCT06858306
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.
Disclaimer
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This is a summary of
the original study
.
Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
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Locations
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Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
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Atrium Health Carolinas Medical Center
Charlotte, North Carolina, 28230, United States
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Centra Medical Group Stroobants Cardiovascular Center
Lynchburg, Virginia, 24501, United States
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Doylestown Health Cardiology
Doylestown, Pennsylvania, 18901, United States
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Houston Methodist Hospital
Houston, Texas, 77030, United States
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Mayo Clinic
Rochester, Minnesota, 55905, United States
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Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407, United States
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Montefiore Medical Center
New York, New York, 10467, United States
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OhioHealth
Columbus, Ohio, 43214, United States
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Piedmont Heart Institute
Atlanta, Georgia, 30309, United States
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Sarasota Memorial Hospital
Sarasota, Florida, 34239, United States
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Texas Health Resources
Fort Worth, Texas, 76104, United States
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University of Alabama at Birmingham Hospital
Birmingham, Alabama, 35294, United States
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University of Virginia Medical Center
Charlottesville, Virginia, 22903, United States