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New heart catheter aims to stop dangerous rhythms in their tracks

NCT ID NCT06703489

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 85 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    6 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Beth Israel Deaconess Medical Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Cleveland Clinic Foundation

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Hospital of the University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Icahn School of Medicine at Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

  • Texas Cardiac Arrhythmia Research Foundation

    RECRUITING

    Austin, Texas, 78705, United States

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

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