Recruiting

New catheter tool to treat dangerous heart rhythm after heart attack

Plain-English translation of NCT07585968 on ClinicalTrials.gov ↗ · Source last updated October 2026 · Translation generated September 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 a new medical device called the Sphere-9™ Catheter combined with the Affera™ Ablation System to treat a dangerous heart rhythm called ventricular tachycardia. Ventricular tachycardia is when your heart beats too fast in an abnormal way, which can be life-threatening. This treatment uses a thin tube (catheter) inserted through blood vessels to reach and carefully eliminate the areas of heart tissue causing the abnormal rhythm.

Many people who have had a heart attack continue to experience dangerous heart rhythms even after taking medication or receiving an implantable defibrillator (a device that shocks the heart back to normal rhythm). Researchers developed this new catheter system to help people whose abnormal heart rhythms keep returning despite these standard treatments.

Do you qualify?

You likely qualify if…

you have had a previous heart attack
you have experienced at least one episode of sustained abnormal heart rhythm in the past 6 months that lasted more than 30 seconds or required your defibrillator to stop it
your abnormal heart rhythm has continued despite taking heart rhythm medications or your defibrillator has had to treat it multiple times
you have had an implantable cardiac defibrillator (ICD) or CRT-D device for at least 2 months before the procedure
you are between 18 and 85 years old

You likely don't qualify if…

you have unstable or constantly occurring abnormal heart rhythms that require life support machines
you have had more than two prior ablation procedures, or more than one within the past year
you have had a recent heart attack (within the past 2 months) or active heart muscle damage
you have very severe heart failure, severe heart valve disease, or a heart assist device
you have had a stroke or mini-stroke within the past 6 months

What participation looks like

You would undergo a catheter ablation procedure where doctors use the Sphere-9™ Catheter and Affera™ system to map and treat the abnormal heart rhythm areas. The procedure involves inserting a thin tube through blood vessels to reach your heart. You would need to complete follow-up visits and testing after the procedure to monitor how well the treatment worked and your overall heart health.

AI-generated summary from trial data · Sep 5, 2026 · Not medical advice

Trial locations(7 sites)

United States

South Denver Cardiology Associates, Littleton, Colorado

Ascension Saint Vincent Hospital - Indianapolis, Indianapolis, Indiana

Northwell Health Lenox Hill Hospital, Manhasset, New York

NYU Langone Medical Center, New York, New York

Atrium Health Wake Forest Baptist Medical Center, Winston-Salem, North Carolina