New heart catheter aims to stop dangerous rhythms in their tracks
NCT ID NCT06703489
First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 2 times
Summary
This study is testing a new device called the Sphere-9 catheter, used with the Affera mapping system, to treat ventricular tachycardia (VT) — a fast, dangerous heart rhythm. The procedure uses heat to destroy small areas of scarred heart tissue that cause the abnormal rhythm. The trial will enroll 60 adults who have had repeated episodes of VT linked to heart scarring. Researchers will check if the procedure is safe and if it can stop VT from happening again.
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 (device)
- What this could lead to
- If successful, this could provide a new, more effective way to treat ventricular tachycardia by precisely destroying the heart tissue causing dangerous rhythms.
- What could go wrong
- This is an early feasibility study with only 60 participants, so results may not apply to everyone. There are risks of serious complications like heart or lung problems from the procedure.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2025
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Any of the following: 1. Ischemic cardiomyopathy (ICM) patients with prior history of myocardial infarction (MI). 2. Non-ischemic cardiomyopathy (NICM) patients with documented myocardial scar in a territory without coronary stenosis as evidenced by cardiac imaging. 2. At least one episode of sustained (continuous for \>30 seconds or requiring ICD intervention for termination) monomorphic ventricular tachycardia within the 6 months prior to enrollment. 3. Recurrence of sustained ventricular tachycardia despite class I or III antiarrhythmic drug therapy or ICD intervention. 4. Implanted with an implantable cardiac defibrillator (ICD) or CRT-D for at least 3 months prior to the ablation procedure. 5. Age 18 through 85 years old. 6. Willing and able to provide informed consent. 7. Willing and able to comply with all pre-, post-, and follow-up testing requirements. Exclusion Criteria: 1. Incessant VT necessitating hemodynamic support prior to the ablation procedure. 2. Unstable polymorphic VT or ventricular fibrillation (VF). 3. VTs due to any of the following: 1. Idiopathic VT 2. Automaticity or triggered activity 3. Lamin or titin genetic mutation 4. Ventricular tachycardia secondary to electrolyte imbalance, active thyroid disease, or any other reversible or non-cardiac cause (e.g., drug induced arrhythmia). 4. NICM subjects with active inflammatory processes (e.g., myocarditis) within 120 days prior to the ablation procedure. 5. VT or VF thought to be from channelopathies. 6. More than two prior VT ablations at any time, more than one prior VT ablation within 12 months prior to the ablation procedure, or any VT ablation within 4 weeks prior to the ablation procedure. 7. Sarcoidosis. 8. Hypertrophic cardiomyopathy, except when due to an apical aneurysm. 9. Unstable angina. 10. Active myocardial ischemia. 11. Type 1 myocardial infarction within 2 months (60 days) prior to the ablation procedure. 12. Any percutaneous coronary intervention within 2 months (60 days) prior to the ablation procedure. 13. Any cardiac surgery within 3 months (90 days) prior to the ablation procedure. 14. Left ventricular ejection fraction (LVEF) \<15%. 15. NYHA Class IV heart failure. 16. Decompensated heart failure. 17. Currently receiving support, or anticipated to receive support prior to the index ablation procedure, via extracorporeal membrane oxygenation (ECMO). 18. Ventricular assist device (VAD) implanted, planned or required for the procedure. 19. Severe aortic or mitral stenosis, or severe aortic or mitral regurgitation. 20. Presence of prosthetic valve in the aortic or mitral valve. 21. Patients with advanced COPD (on home oxygen). 22. Presence of intracardiac thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation. 23. Thromboembolic event (stroke or transient ischemic attack) within 6 months (180 days) prior to the index ablation procedure or with neurologic deficit. 24. Left atrium (LA) or left ventricle (LV) intracardiac thrombus on imaging. 25. Severe bleeding, clotting or thrombotic disorder, or thrombocytopenia (defined as platelet count \<80,000). 26. Contraindication to anticoagulation. 27. End-stage renal disease (requiring dialysis). 28. Acute illness, active infection, or sepsis. 29. Life expectancy less than 12 months. 30. Any woman known to be pregnant or breastfeeding, or any woman of childbearing potential who is not on a reliable form of birth regulation method or abstinence. 31. Body mass index \>45 kg/m2. 32. Known ongoing drug or alcohol dependency. 33. Current or anticipated participation in any other ongoing study of a drug, device, or biologic during the duration of the study not pre-approved by the Sponsor. 34. Vulnerable subjects (such as a prisoner, handicapped or mentally disabled person, or person under tutelage or guardianship). 35. Any other condition that, in the opinion of the investigator, would preclude enrollment in this study or compliance with follow-up requirements or would pose a significant hazard to the subject if an ablation procedure were performed.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beth Israel Deaconess Medical Center
RECRUITINGBoston, Massachusetts, 02215, United States
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Cleveland Clinic Foundation
RECRUITINGCleveland, Ohio, 44195, United States
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Hospital of the University of Pennsylvania
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
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Icahn School of Medicine at Mount Sinai
RECRUITINGNew York, New York, 10029, United States
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Texas Cardiac Arrhythmia Research Foundation
RECRUITINGAustin, Texas, 78705, United States
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Vanderbilt University Medical Center
RECRUITINGNashville, Tennessee, 37232, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- The heart rhythm threat hiding in heart attack wards
- Mapping the Heart's hidden short circuits: a new ablation strategy for dangerous rhythms
- AI may spot deadly heart rhythms before they strike
- Can we predict dangerous heart ablation risks?
- Can a chest scan shortcut dangerous heart rhythm surgery?
- Heart device data may unlock secrets of rare heart muscle disease