Testing a new catheter device to treat dangerous heart rhythms

Plain-English translation of NCT06703489 on ClinicalTrials.gov ↗ · Source last updated June 2026 · Translation generated June 2026 · How we translate trials

This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.

What is this trial?

This trial is testing the Sphere-9™ Catheter and Affera™ Ablation System — a new minimally invasive procedure to treat ventricular tachycardia, a dangerous heart rhythm disorder. Ventricular tachycardia happens when the lower chambers of the heart beat too fast or irregularly, often in patients who have had a heart attack or have scarred heart tissue. This treatment is designed for people whose dangerous rhythms keep coming back despite taking heart medications or having a defibrillator.

Many patients with scar-related heart rhythms continue to have life-threatening episodes even after receiving standard treatments like medications and implanted defibrillators. This trial aims to see if this new ablation device can safely and effectively stop these dangerous rhythms by targeting and removing the scar tissue causing them.

Do you qualify?

You likely qualify if…

you have had a heart attack with scarring, or you have a non-ischemic heart condition with documented scar tissue
you have experienced at least one episode of sustained ventricular tachycardia in the past 6 months
your dangerous heart rhythms continue to occur despite taking anti-arrhythmic medications or having an implanted defibrillator
you have had an implanted cardiac defibrillator or pacemaker for at least 3 months
you are between 18 and 85 years old and willing to follow all study requirements

You likely don't qualify if…

you have unstable or changing heart rhythms that require emergency life support
you have had more than two prior ablation procedures, or another ablation within the past 4 weeks
you have had a recent heart attack (within 2 months), recent heart surgery (within 3 months), or recent coronary stent placement (within 2 months)
you have very weak heart function (ejection fraction below 15%), severe heart failure, or are on advanced life support
you have had a stroke or mini-stroke within the past 6 months

What participation looks like

If you qualify, you will undergo a cardiac catheter ablation procedure using the new Sphere-9 device. During this minimally invasive procedure, doctors will thread a specialized catheter through your blood vessels to your heart to identify and treat the scar tissue causing your dangerous rhythms. You will need to complete follow-up visits and testing after the procedure to monitor your heart rhythm and overall heart health.

AI-generated summary from trial data · Jun 22, 2026 · Not medical advice

Trial locations(6 sites)

United States

Beth Israel Deaconess Medical Center, Boston, Massachusetts

Icahn School of Medicine at Mount Sinai, New York, New York

Cleveland Clinic Foundation, Cleveland, Ohio

Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania

Vanderbilt University Medical Center, Nashville, Tennessee